Warehouse Supervisor/Manager

Operations Supervisor

Digital Marketing Specialist

Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

Responsibilities: Distribution Operations <ul><li>Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory.</li><li>Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries.</li><li>Maintain and administers all departmental policies, SOP’s and training.</li></ul> Compliance and Audit <ul><li>Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li></ul> Cross-Functional Support <ul><li>Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul> Requirements: Education &amp; Experience	 <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Minimum of a Bachelor’s Degree, preferably with a Business, Technical and /or Supply Chain focus.</li><li>Minimum of 8 years’ experience in Supply Chain Operations.</li><li>Project management experience preferred.</li><li>Experience with Six Sigma/Process excellence tools, training or certification.</li><li>Shipment of Hazardous Material transportation certification.</li><li>APIC’s certification preferred.</li><li>Knowledge Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Knowledge of US and international transportation and distribution practices.</li><li>Knowledge of Code of Federal regulations Title 21 part 210 and 211, and DEA rules and regulations for distribution/storage/manufacture of controlled substances is a must.</li><li>Must have working knowledge of serial shipping container code (SSCC).</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Strong communication, collaboration, and organizational skills.</li><li>Results oriented - identifies issues and drives the decision process.</li><li>Ability to effectively challenge assumptions/decisions and support the minority viewpoint when needed.</li><li>Influence management – ability to work cross-functionally at all levels.</li><li>Creative innovation skills, excellent influencing skills, and strong design and visualization capability.</li><li>Deals well with conflict – negotiator, mediator.</li><li>Collaborates with team members on plans (and holds team members accountable).</li><li>Good problem-solving skills, sound judgment.</li><li>Take decisive action and deliver tangible results in a fast-paced cross-functional organization and highly competitive industry.</li></ul> Physical Requirements: <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Able to sit and stand for up to 8 hours.</li><li>Able to walk through production areas.</li><li>Able to lift up to 30 lbs.</li><li>Distribution Operations Oversee all distribution operations for the warehouse, assuring timely accurate and cost-effective deliveries.</li><li>Direct cycle counting procedures to maintain accurate inventory. Review all transportation billing for accuracy before sending to AP.</li><li>Execute contract customer shipments to ensure timely deliveries. Maintain and administers all departmental policies, SOP’s and training.</li><li>Compliance and Audit Ensure compliance with all safety and regulatory guidelines.</li><li>Maintain the warehouse, shipping/receiving areas and distribution center in audit ready condition including upholding a strict level of cleanliness.</li><li>Ensure that all documentation is up to date and easily accessible.</li><li>Maintain an on-going relationship with Supply Chain for inventory and shipments issues.</li><li>Must be current with all federal counterfeit drug regulations, E-pedigree state laws and ASN rules and regulations with the wholesalers.</li><li>Cross-Functional Support Maintain training records for all colleagues in your organization and ensure 100% compliance to training guidelines.</li><li>Work with finance on a monthly basis to ensure all shipments and customer orders have been processed are resolved for months end.</li><li>Works closely with Quality and Regulatory on all related issues. anticipates in audits as needed.</li></ul>

Role Description: <ul><li>Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 2nd shift operations, 3:15pm to 11:45pm.&nbsp;</li><li>This role ensures that all production operations comply with cGMP, safety standards, and production schedules.</li><li>The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Oversees and coordinates Manufacturing and Packaging operations.&nbsp;</li></ul> Responsibilities: Key Accountabilities: <ul><li>Accountability Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.).</li><li>Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts.</li><li>Ensure timely execution of production schedules.</li><li>Monitors manufacturing and packaging processes to ensure schedule is met within standards.</li><li>Review and complete shift documentation, including batch documentation, logbooks, etc.</li><li>Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift Support investigations for deviations that occur during the shift.</li><li>Assist in determining and implementing CAPA.</li><li>Provide training, guidance, and performance feedback for shift employees.</li><li>Ensure training requirements are met.</li><li>Support employee development and cross-training.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li></ul> Continuous Improvement <ul><li>Captures and reports metrics; troubleshoots downtime to increase operational efficiency.</li><li>Lead or participate in Continuous Improvement projects.</li><li>Troubleshoots and resolves process issues.</li></ul> Issues &amp; Deviations <ul><li>Performs defect evaluations and initiates production events.</li><li>Identifies, reports, and suggests resolutions for processing related issues.&nbsp;</li><li>Assists in the investigation of unplanned deviations.</li></ul> Teamwork and Collaboration <ul><li>Provides priorities for the off-shift operations, focusing resources on priority products.</li><li>Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues.</li><li>Continuous Training Ensures personnel are current with training requirements.</li><li>Stays current on SOPs and cGMPs.</li><li>Continuous Safety &amp; Compliance Contribute to safety audits.</li><li>Ensures out manufacturing/packaging activities safely, as required, on a daily basis.</li><li>Follows all safety and compliance procedures and participates in required training.</li><li>Adheres to all cGMP compliance/regulatory mandates and quality requirements.</li><li>Participate in safety teams, start-up discussions, incident debriefs, etc.</li><li>Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.</li><li>Misc Other related duties as assigned to meet departmental and Company objectives.&nbsp;</li></ul> Requirements: Qualifications Education &amp; Experience: <ul><li>Minimal acceptable level of education, work experience and certifications required for the job Bachelor’s degree in pharmacy, Chemistry, Engineering, or a related discipline preferred, relevant experience my substitute.</li><li>Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging.&nbsp;</li><li>Knowledge Proficiency in a body of information required for the job e.g.</li><li>Knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Thorough knowledge of cGMP and FDA regulations.</li><li>Thorough knowledge of manufacturing and packaging operations.&nbsp;</li></ul> Skills &amp; Abilities: <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Demonstrated leadership, communication, and decision-making skills.</li><li>Ability to oversee and manage the daily operations of manufacturing and packaging. Ability to monitors processes to ensure schedule is met within standards.</li><li>Ability to analyze metrics and troubleshoot downtime.&nbsp;</li><li>Effectively interfaces with Quality Assurance to inform of deviations or other line issues.</li><li>Demonstrates the ability to work in collaboration with others as a part of a team.</li><li>Ability to lead in Continuous Improvement projects.</li><li>Possess technical writing skills.&nbsp;</li><li>Physical Requirements Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Must be able to stand for long periods of time (8- or 12-hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li></ul>

Role Description:&nbsp; <ul><li>Our client is seeking a dynamic and results-driven Digital Marketing Specialist to join our team on a freelance, project-based basis.</li><li>The ideal candidate will have hands-on experience in digital marketing, influencer marketing, and new media channels like podcasts, with a strong background in performance marketing.</li><li>This role offers an exciting opportunity to work with a growing company in the following industries: OTC Healthcare/Consumer Goods/Health and Wellness/E-commerce.</li></ul> Responsibilities: <ul><li>Partner with brand marketers to understand brand strategy, tactical plans, campaign requirements, data needs, and operational support associated with their digital marketing efforts</li><li>Plan and carry out marketing and promotional activities for the brand.</li><li>Ensure timely and compliant delivery of operational responsibilities in accordance with project milestones.</li><li>Serve as a subject matter expert for digital marketing best practices, internal processes, and systems related to digital marketing.</li><li>Help brand marketers ensure adequate data capturing and reporting are in place for all digital marketing initiatives.</li><li>Facilitate continued educational/training opportunities for internal marketing stakeholders and external agency teams</li><li>Gather future business requirements and represent the voice of the brand as additional digital marketing capabilities/platforms are established.</li><li>Cultivate strong partnerships with external agency teams, suppliers, and vendors in support of Brand and/or Digital Operations efforts.</li><li>Lead and execute media plans; Identify and optimize digital channel mix to help grow the brands.</li><li>Oversee all digital paid advertisements and third-party digital vendor management.</li><li>Analyze data by mapping current digital tactics to identify gaps, opportunities, and insights to optimize spend, performance &amp; ROI</li><li>Proficiency in core marketing capabilities such as digital creative development, segmentation, investment optimization, etc.</li><li>Experience in managing multiple external agency partners and internal marketing partners to meet deadlines in alignment with SOWs.</li><li>Work with overseas counterparts to ensure alignment of brand objectives.</li><li>Plan, conceptualize, and develop new product launches.</li><li>Manage media communication, advertising, and campaign/promotion on both offline and online (social media, Facebook, Instagram)</li><li>Manage brand presence in social networking sites including Facebook, Twitter, and other relevant blogs, sites, e-commerce, and forums</li><li>Monitor social media for conversations and trends related to company brand and feedback insights to the Regional to align overall business strategy</li><li>Measure the impact of social media programs; analyze, review and report on the effectiveness of our company’s social&nbsp;</li></ul> Requirements: <ul><li>Bachelor’s degree (or) masters degree in marketing or related fields.</li><li>6+ years of relevant experience, preferable within the bio/pharma industry with at least 5 years of digital marketing experience</li><li>Exceptionally strong analytical skills, Communication Skills with the ability to evaluate KPIs, present learnings based on data and optimize</li><li>In-depth knowledge of digital marketing within the pharmaceutical or healthcare industry.</li><li>Freelance, Project-Based Work: Must be willing to work on a freelance, project basis, with flexibility on timelines and deliverables.</li><li>Operational Experience: Must have direct operational experience in digital marketing, influencer marketing, and new media, including podcasts.</li><li>Performance Marketing Expertise: Proven experience in performance marketing, with a focus on driving measurable results like conversions and ROI.</li><li>Proficiency in managing paid campaigns across multiple platforms (Google Ads, Meta, TikTok).</li><li>Experience in managing Influencer campaigns on Social Media platforms like Tik Tok, YouTube shorts and Meta.</li><li>Industry Experience: Experience in OTC healthcare, consumer goods, or consumer services is required.</li><li>Strong experience working closely with advertising agencies.</li><li>Self-Motivated &amp; Independent: Ability to manage projects independently and deliver results with minimal supervision.</li><li>Strong Communication Skills: Excellent written and verbal communication skills, with the ability to engage and collaborate with both internal teams and external partners.</li></ul> Why Join Us: <ul><li>Growth Opportunity: Be a part of a rapidly expanding company with a strong entrepreneurial culture.</li><li>Flexibility: Enjoy a remote working environment.</li><li>Impact: Play a crucial role in expanding the profile and reach of “Our client” and its brands in the US market. </li><li>If you are a motivated, strategic thinker with a passion for consumer marketing and sales, we invite you to apply and join our dynamic team at our client.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

Responsibilities: <ul><li>Material/Product Review &amp; Release:</li><li>Review raw material and finished product testing result records, including Certificates of Analysis (C of A), Certificates of Conformance (C of C), and laboratory reports to confirm accuracy.&nbsp;&nbsp;</li><li>Determine the acceptability of materials/products for release based on compliance with specifications and testing results.&nbsp;&nbsp;</li><li>Perform ERP transactions for the release, hold, or rejection of raw materials and finished products.&nbsp;&nbsp;</li><li>Prioritize raw material review and release based on production scheduling requirements.&nbsp;&nbsp;</li></ul> Requirements: <ul><li>Minimum 5-12 years of experience in the pharmaceutical industry related to material/product review, release, and laboratory functions.&nbsp;&nbsp;</li><li>Expertise in reviewing and managing GMP documents, raw material and product testing, and quality systems.&nbsp;&nbsp;</li><li>Proficiency with laboratory systems and software tools such as LIMS, SAP, and EMPOWER.&nbsp;&nbsp;</li><li>Strong understanding of regulatory guidelines, including FDA, EMA, and ICH, as well as industry standards and best practices.&nbsp;&nbsp;</li></ul>

Job Description: <ul><li>We are seeking a highly motivated Scheduling &amp; Production Planning Analyst with expertise in inventory management and advanced Excel modeling skills.</li><li>The ideal candidate will have 2-3 years of experience in scheduling, production planning, and inventory management, with a strong ability to leverage Excel to optimize processes and improve efficiency.</li><li>A background in finance is an added advantage, helping to drive decisions on new business opportunities, cost analysis and budget management within production and inventory functions.</li><li>In this role, you will be responsible for developing and managing production schedules, optimizing inventory levels, forecasting demand, and analyzing data to support decision-making.&nbsp;</li><li>Your advanced Excel skills will be crucial in creating models for production, inventory planning, and reporting, while your understanding of finance will help identify cost-optimization opportunities.</li></ul> Responsibilities: Production Scheduling &amp; Planning: <ul><li>Develop and manage production schedules, ensuring efficient resource allocation (labor, equipment, raw materials) and meeting production deadlines. Work closely with cross-functional teams to align production goals with business objectives.</li></ul> Inventory Management: <ul><li>Monitor inventory levels and ensure alignment with production schedules.&nbsp;</li><li>Optimize inventory to minimize holding costs and reduce the risk of stockouts or overstock situations.</li></ul> <ul><li>Advanced Excel Modeling: </li></ul> <ul><li>Utilize advanced Excel skills to build and maintain models for production planning, inventory optimization, and scheduling. </li><li>This includes using pivot tables, complex formulas, forecasting, data visualization, and macros to enhance decision-making and operational efficiency.</li></ul> Forecasting &amp; Demand Planning: <ul><li>Work with sales, procurement, and other teams to develop accurate demand forecasts, ensuring production schedules are aligned with customer needs and market trends.</li></ul> Capacity &amp; Resource Planning: <ul><li>Analyze production capacity and resource availability, adjusting schedules and inventory management to meet changing demands and operational constraints.</li></ul> Cost Management &amp; Financial Analysis: <ul><li>Collaborate with finance teams to monitor production and inventory costs, identify inefficiencies, and help with cost optimization strategies.&nbsp;finance background will assist in budgeting and forecasting for production-related topics.</li></ul> Performance Reporting: <ul><li>Prepare and present regular reports on production performance, inventory levels, and key performance indicators (KPIs). Provide data-driven insights and recommendations to improve efficiency, reduce costs, and meet business goals.</li></ul> Process Optimization: <ul><li>Continuously assess and refine production planning, scheduling, and inventory management processes. Recommend and implement improvements to reduce waste, increase throughput, and optimize resource utilization.</li></ul> ERP System Utilization: <ul><li>Use ERP systems (SAP) to manage production and inventory data, ensuring accurate tracking of orders, materials, and resources.</li></ul> Requirements: <ul><li>Bachelor’s degree in supply chain management, Operations, Business, Finance, or a related field.</li><li>2-3 years of experience in scheduling, production planning, and inventory management.</li><li>Advanced proficiency in Microsoft Excel, including pivot tables, VLOOKUP, advanced formulas, forecasting models, macros, and data analysis.</li><li>Strong understanding of production scheduling, inventory management, and supply chain processes.</li><li>A background in finance or financial analysis is an added advantage, helping to identify cost-optimization opportunities and manage budgets effectively.</li><li>Familiarity with ERP systems (e.g., SAP) and other inventory management tools.</li><li>Strong analytical skills and the ability to interpret complex data and generate actionable insights.</li><li>Excellent communication and collaboration skills, with the ability to work cross-functionally with teams across the organization.</li><li>Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.</li></ul> Preferred Qualifications: <ul><li>Certification in Supply Chain Management or Finance-related qualifications (e.g., MBA) is a plus.</li><li>Experience with data visualization tools (e.g., Power BI, Tableau) for reporting and dashboard creation.</li><li>Knowledge of production planning software or inventory management systems is beneficial.</li></ul>

Role Description: <ul><li>Position Overview: We are seeking a skilled and detail-oriented Electrical/Controls Technician to join our pharmaceutical operations team. </li><li>The successful candidate will be responsible for the installation, maintenance, troubleshooting, and repair of electrical control systems used in pharmaceutical manufacturing and packaging processes. </li><li>This role is critical to ensuring operational efficiency, product quality, and compliance with regulatory standards.&nbsp;</li></ul> Responsibilities:&nbsp; Installation and Maintenance:&nbsp; <ul><li>Install and maintain electrical control systems, PLCs (Programmable Logic Controllers), HMIs (Human-Machine Interfaces), and SCADA systems.&nbsp;</li><li>Perform routine preventive maintenance on electrical systems to minimize downtime and ensure continuous operation.&nbsp;</li><li>Test and validate electrical control systems during commissioning and upgrades.&nbsp;</li></ul> Troubleshooting and Repairs:&nbsp; <ul><li>Diagnose and resolve malfunctions in electrical systems, instrumentation, and automation equipment.&nbsp;</li><li>Utilize diagnostic tools, schematics, and software to identify root causes of system failures.&nbsp;</li><li>Repair or replace faulty components, including relays, sensors, actuators, and circuit boards.&nbsp;</li></ul> System Optimization:&nbsp; <ul><li>Program, configure, and optimize PLCs, HMIs, and VFDs (Variable Frequency Drives) to improve system performance and efficiency.&nbsp;</li><li>Assist in the design and implementation of new electrical control systems for process improvements and new projects.&nbsp;</li><li>Conduct system performance tests to ensure compliance with specifications and regulatory requirements.&nbsp;</li></ul> Documentation and Compliance:&nbsp; <ul><li>Maintain accurate documentation of electrical control systems, including wiring diagrams, and maintenance logs.&nbsp;</li><li>Ensure all activities comply with GMP (Good Manufacturing Practices), FDA, and other regulatory guidelines.&nbsp;</li><li>Participate in audits and provide technical expertise regarding control systems and maintenance records.&nbsp;</li></ul> Safety and Training:&nbsp; <ul><li>Adhere to safety protocols and ensure that all electrical work complies with NFPA, OSHA, and company standards.&nbsp;</li><li>Conduct risk assessments for electrical systems and implement appropriate safety measures.&nbsp;</li><li>Provide technical training to maintenance personnel on electrical systems and best practices.&nbsp;</li></ul> Collaboration:&nbsp; <ul><li>Work closely with engineering, production, and quality assurance teams to ensure electrical systems support manufacturing requirements.&nbsp;</li><li>Communicate effectively with equipment vendors and contractors for system upgrades and troubleshooting.&nbsp;</li></ul> Requirements: <ul><li>Education: Associate’s degree in electrical engineering, electronics, or a related field.&nbsp;</li><li>Experience: Minimum of 3-5 years in electrical controls, automation, or instrumentation, preferably in a pharmaceutical or regulated industry.&nbsp;</li><li>Technical Skills: Proficiency in PLC programming (e.g., Allen-Bradley, Siemens).&nbsp;</li><li>Strong understanding of electrical schematics, control wiring, and instrumentation.&nbsp;</li><li>Familiarity with SCADA systems and industrial networks.&nbsp;</li><li>Knowledge of GMP and regulatory standards in the pharmaceutical industry.&nbsp;</li></ul> Certifications: <ul><li>Relevant certifications (e.g., Journeyman Electrician, ISA Technician Certification) are a plus.&nbsp;</li></ul> Key Competencies:&nbsp; <ul><li>Analytical problem-solving skills with attention to detail.&nbsp;</li><li>Ability to work independently and as part of a team.&nbsp;</li><li>Excellent communication and documentation skills.&nbsp;</li><li>Commitment to safety, quality, and regulatory compliance.&nbsp;</li></ul>

Role Description: <ul><li>The Lead Quality Specialist - Investigator serves as the primary investigator for Out of Specification (OOS), Out of Trend (OOT), Non-Official Events (NOE), and other laboratory investigations within the Quality Control (QC) department.</li><li>This role is responsible for initiating, conducting, and closing laboratory investigations while collaborating with cross-functional teams to ensure accurate root cause analyses, effective Corrective and Preventive Actions (CAPAs), and adherence to compliance requirements.</li><li>Frequent interaction with QC, QA, Manufacturing, and other departments is essential to achieve timely investigation closure and process improvements.</li></ul> Scope of Authority <ul><li>Provides investigative and compliance support to the QC laboratory, with a focus on maintaining quality standards and supporting cross-departmental collaboration.</li></ul> Responsibilities; 1. Initiation, Execution, and Closure of QC Lab Investigations (60%) <ul><li>Initiate and conduct OOS, OOT, and NOE investigations in alignment with procedural timelines.</li><li>Provide support and guidance to QC teams during execution, writing, and closure of investigations.</li><li>Conduct interviews with QC personnel to gather information and complete investigation reports in Trackwise.</li><li>Utilize laboratory software for root cause and impact analyses.</li><li>Conduct quality walkthroughs in the QC laboratory to identify and address compliance issues.</li><li>Regularly communicate with departmental leaders to provide updates on investigation progress and documentation needs.</li></ul> 2. Corrective and Preventive Actions (CAPAs) (30%) <ul><li>Collaborate with cross-functional teams to identify, implement, and monitor CAPAs within QC laboratories.</li><li>Assist with training, procedure updates, and monograph revisions based on investigation outcomes.</li><li>Provide recommendations for process improvements to support continuous improvement initiatives.</li></ul> 3. Compliance (10%) <ul><li>Identify compliance risks, propose remediation strategies, and lead the implementation of solutions.</li><li>Provide compliance expertise, training, and support to QC and other impacted departments.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences.</li><li>Minimum of 4 years of experience in a pharmaceutical manufacturing environment.</li></ul> Knowledge <ul><li>Proficiency in HPLC, GC, and related chromatography methods and equipment.</li><li>Working knowledge of Chromatographic Data Systems (e.g., Empower preferred) and applications such as Trackwise.</li><li>Comprehensive understanding of QC lab testing and data integrity principles.</li><li>Familiarity with regulatory requirements, including 21-CFR-210, 21-CFR-211, ICH Guidelines, and Compendia standards (USP, EP, JP, etc.).</li></ul> Skills &amp; Abilities <ul><li>Strong technical writing and documentation skills.</li><li>Problem-solving and decision-making expertise.</li><li>Excellent communication skills with peers, chemists, and senior management.</li><li>Critical thinking and root cause analysis proficiency.</li><li>Customer and stakeholder focus, with a strong commitment to quality and integrity.</li><li>Physical &amp; Mental Requirements</li><li>Ability to sit, stand, walk, and use a computer for extended periods.</li><li>Exposure to moderate noise levels and various chemicals in an FDA- and DEA-regulated environment.</li><li>Ability to wear personal protective equipment (e.g., gloves, respirators).</li><li>Specific vision requirements include close vision and color vision.</li></ul>

Responsibilities: <ul><li>Coordinates each Operator’s responsibilities during each shift.</li><li>Monitors the packaging process to ensure schedule is met within standards.</li><li>Conducts final audit of Batch Records, including MAPICS transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running all packaging equipment across the entire packaging department.</li><li>Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy.</li><li>Accurately reviews BPRs steps for completeness and accuracy.</li><li>Request components, labels and inserts per the BPR.</li><li>Set up packaging machinery; accurately sets equipment programming according to BPRs and SOPs.</li><li>Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines.</li><li>Conduct sampling: Collects samples from each batch and submits to QA for retained samples.</li><li>Executes procedures to complete tasks in a compliant and safe manner.</li><li>Conducts verification of line/equipment cleaning and documents per SOP.</li><li>Executes procedures used to clean pharmaceutical packaging equipment and facilities.</li><li>Competently conducts Master Cleans and Line Clearances.</li></ul> Requirements: <ul><li>Must be able to stand for long periods of time (8 or 12 hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.</li><li>Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.</li><li>Vision - ability to see details at close range (within a few feet of the observer).</li><li>Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.</li></ul>

Responsibilities: <ul><li>Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc.&nbsp;</li><li>Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOPs.</li><li>Executes written SOPs to ensure the purity of materials involved in the manufacturing process.</li><li>Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.</li><li>Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.</li><li>Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs.</li><li>Executes machine change-overs from batch to batch.</li><li>Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator.</li><li>Learns sampling techniques.</li><li>Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debriefing session to understand the reasons why and what needs to be corrected moving forward.</li><li>Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.</li><li>Meets requirements for entries on all applicable batch production pages, completion and attachment of all dispensary and weight verification tickets.</li><li>Verifies the manufacturing process on BPR in an accurate and timely manner.</li><li>Provides status updates and operational challenges on status boards.</li></ul> Requirements: <ul><li>HS diploma or equivalent at minimum, with 0-2 years’ related experience*</li><li>Forklift certification may be required for blending and granulation.</li><li>Knowledge of cGMPs.</li><li>Has solid working knowledge and skills in procedures, techniques, tools, materials and/or equipment needed for the position.&nbsp;&nbsp;</li><li>Basic math, reading, legible writing skills, and problem solving abilities.&nbsp;</li></ul>

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Warehouse Supervisor/Manager

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Digital Marketing Specialist

Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

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16 chestnut ridge Jobs found

Warehouse Supervisor/Manager

Operations Supervisor

Digital Marketing Specialist

Quality Control Supervisor

Analytical Quality Assurance Specialist

Scheduling & Production Planning Analyst

Electrical/Controls Technician

Lead Quality Specialist - Investigator

Senior Packaging Technician

Manufacturing Operator II

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WhiteCrow is on a mission to connect companies with the best talent across the globe.