Sanitation Assistant Manager

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Production Manager

Associate I, Quality Operations

Specialist, DEA Compliance

Role Description: <ul><li>To verify and monitor plant sanitation and hygiene requirements.</li><li>Ensure all food safety and quality-related documentation is up-to-date.</li><li>Monitor GMP and sanitation hygiene standards within the manufacturing plant.</li><li>Lead the HACCP team and oversee development and updates for both existing and new product lines.</li></ul> Responsibilities:&nbsp; Plant Hygiene &amp; Sanitation Compliance: <ul><li>Ensure compliance with MSS and SSOP standards and train operating staff accordingly.</li><li>Conduct cleaning verification inspections and drive hygiene and sanitation standards across the plant.</li><li>Execute daily sanitation, Safety &amp; Hygiene (S&amp;H), Golden Gemba audits, and ensure timely closure of findings. Quality Systems &amp; Documentation</li><li>Create, maintain, and review all Food Safety and Quality records and documentation.</li><li>Enter and manage relevant data within internal quality systems/software. HACCP &amp; Pest Management</li><li>Lead HACCP team activities including plan development, implementation, and periodic review.</li><li>Oversee factory-wide pest control operations: analyze trends, conduct audits, and troubleshoot issues.</li></ul> Requirements: Experience: <ul><li>3–5 years in the quality function within the food industry</li><li>Hands-on experience with:</li><li>HACCP</li><li>BRC or equivalent Quality Management Systems</li><li>Plant sanitation compliance and control practices</li></ul>

Reponsibilities: Product Level Strategy <ul><li>Market data and internal financials</li><li>Strategy (gain share, hold share, rationalize volume, improve price, etc.)</li><li>Target share</li><li>Inventory targets based on market dynamics, product strategy, etc.</li><li>Provides input for Product Champions</li><li>Decision-making for Day-to-day Commercial Operations</li><li>Incorporate Product Strategies while leading/making the following decisions:</li><li>Order processing</li><li>ROFR responses</li><li>New business bids</li></ul> Rolling 12-month forecasts <ul><li>New Product Intel and Near-term Launch Evaluation &amp; Tracking</li><li>Maintain master database of future product pipeline information at the customer level.</li><li>Share with Portfolio as needed.</li><li>Assess the right frequency of pricing &amp; volume intel requirements</li><li>Interpret the accuracy of intel based on existing data points and those gathered via subscriber information (IQVIA, export data, etc.)</li><li>Rolling 12-month New Product Launch Prioritization and Planning</li></ul> Tracking results vs. business case on new launches <ul><li>Provide leadership for Product Management, Pricing/Contracts, Customer Service, Forecasting and Marketing</li><li>Identify/execute process improvements, including IT solutions</li><li>Manage all aspects of OTB strategies &amp; tactics (price, vol, production)</li><li>Improve UPS execution and shipping costs while analyzing other 3PLs</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor’s or master’s degree preferred</li><li>10 plus years related work experience in the pharmaceutical industry, preferably generics</li><li>Excellent computer skills, including data collection experience</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>Industry/Customer recognition</li><li>Financial acumen</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>Interpersonal Skills - Focuses on solving conflict; Maintains confidentiality; works well in a collaborative environment</li><li>Adapts to changes; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes or unexpected events. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</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>General Office environment</li><li>Occasional Travel</li></ul>

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: <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>

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>

Roles &amp; Responsibilities: <ul><li>Supervising production processes and ensuring that quality work is done safely and efficiently.</li><li>Liaising with other engineers to develop plans that improve production, costs, and labor required.</li><li>Developing and monitoring production-related cost saving projects, encouraging the team to develop cost saving projects and reporting them.</li><li>Diagnose problems on the production line and provide recommendations and training by usining KWS Loss analaysis methodology.</li><li>Establishing safety procedures and protocols that consider workers well-being while minimizing the carbon footprint.</li><li>Staying informed about developments in engineering and production and sharing information with colleagues.</li><li>Identifying, documenting and reporting unsafe practices.</li><li>Preparing production schedules and budgets for projects.</li><li>Planning meetings with relevant departments and stakeholders.</li><li>Analyzing all aspects of production and making recommendations for improvement.</li><li>To make all equipment efficiency calculations and reports on a daily and monthly basis.</li><li>Planning, implementing and monitoring actions that will increase efficiency.</li><li>Taking actions by making suggestions to reduce material losses and increase the quantity of quality products.</li><li>Responsible for organizing production areas and carrying out production in accordance with the weekly plan.</li><li>KWS, QFS, EHS COE team member.</li><li>Attending the Tier 4 DDS meeting on a daily basis, following the actions determined at the meeting, and forwarding the items escalated from the Tier 2,3 meetings to the Tier 4 meeting.</li><li>To ensure that all Prerequisite Programs (PRP) within the HACCP plan are sustainable and developed. Following up program requirements with relevant parties.</li><li>Ensuring that Food Safety and GMP rules are implemented in production areas.</li><li>To analyze the situations that occur/may occur during the process and to take corrective and preventive actions.</li><li>Participating in internal and external audits. To work to complete audit actions.</li></ul> Requirements: <ul><li>A Bachelor of Engineering is a must, preferably should have master’s degree.</li><li>Overall experience of 7+ Years</li><li>Strong communication skills.</li><li>Strong leadership ability.</li><li>Excellent skills with problem solving, critical thinking and analytical thinking.</li><li>Proven experience in engineering.</li><li>Ability to make decisions under pressure.</li><li>Excellent skills in written and verbal communication.</li></ul>

Responsibilities:The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging.Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues.Communicates to multiple departments and supervision to provide timely process and issue updates.Identifies and escalates issues or problems to appropriate supervision. Participates as a team member on cross-functional teams.Participates in reviews and structured processes for continuous improvement.  Quality Operations:Performs physical inspection of in-process and finished product samples as assigned and according to the production schedule.Collects samples from manufacturing and packaging according to the defined Batch Production Record and procedure requirements.Becomes competent in processes: Weighing, Blending, Granulation, Compression, Coating, Encapsulation, Packaging.Follows internal processes related to controlled substances.Performs GMP related verifications such as line clearances, cleaning, room inspection, and materialsCollects and appropriately labels packaging retain samples, and submits to the archive storageMay execute computer data entries in CME, JDE, LIMS, and/or department databases.Collects retain samples and performs sample evaluation for Annual Product Review.May backup third party product review/release.Perform sampling of Active Pharmaceutical Ingredients, excipients, and packaging components for release testing.Non-conforming events:Responds to and escalates events identified during production to Quality Management.Participates in investigations with the Rapid Response Team as needed.Process Improvement:Collaborates with Manufacturing and Quality partners to identify and implement improvements.Compliance:Conducts GMP walkthroughs of facilitiesLearns how to perform in-process audits to identify adherence to SOPs and BR requirements.Actively participates in training events, and maintains currency with assigned training requirements.Safety:Follows all procedures to ensure a safe and compliant work environment.Requirements:Education & Experience:High school diploma or equivalent with 2-4 years of relevant industry experience (Oral Solid Dose pharmaceutical manufacturing and Quality Assurance experience preferred)Ability to communicate and work with teams.Attention to detail.Strong documentation skills.Ability to read and interpret SOPs and function within the scope of procedures.

Role Description:The DEA Compliance Specialist, under general supervision, is knowledgeable on all matters of the DEA as it pertains to pharmaceutical testing, manufacturing and distribution of controlled substances.Those matters include licenses, procurement, and movement of material, production, shipment and destruction.Incumbent should also have the ability to interface with governmental agencies and represent the company as needed.Responsibilities:DEA coordinator for CII –CV controlled substances: manages/coordinates all DEA-related actives at siteReviews and releases daily orders through Suspicious Order Monitoring System (SOMs) and assures compliance with Suspicious Orders Reporting (SORS)Maintains Know your Customer (KYC) informationConducts year‐end and biennial inventory and report ARCOS quarterly reporting & cycle count inventory via DEA websiteCoordinates all movement of controlled substances from manufacturing through analytical testingLiaises with Procurement and DEA regarding import/export of controlled substance and completes necessary paperworkMaintains compliance of all DEA, State, and Board of Pharmacy registrationsCoordinates all controlled substance destruction with QC, Environmental, Health & Safety and Logistic departmentsWorks with Security department to maintain facility upgrades to security systemsPower of Attorney to sign DEA 222 form, responsible for completing, maintaining and tracking all DEA 222 formsResponsible for submitting CII quota applications to DEA; maintain organized DEA files on related activitiesCoordinates and documents DEA audits for sites and issues audit reports to management upon completionRemains current on DEA regs in order to address organization business needsCreates all destruction reports and coordinates pick ups for controlled destruction from MRB, line waste and lab waste.SOPs:Updates associated SOP’s related to job functionsSupporting responsibilities: Back up to State Licensing associateParticipates and represents department at project meetings as requiredRequirements:Education & Experience:Bachelor’s degree in a relevant field required2+ years’ relevant work experienceExperience with IQVIA SOM software preferredWorking knowledge of GMP regulations and compliance issuesStrong knowledge of DEA and FDA regulationsKnowledgeable of production and production planning processes

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11 gmp Jobs found

Sanitation Assistant Manager

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Production Manager

Associate I, Quality Operations

Specialist, DEA Compliance

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11 gmp Jobs found

Sanitation Assistant Manager

Head of Commercial Operations

Warehouse Supervisor/Manager

Operations Supervisor

Quality Control Supervisor

Analytical Quality Assurance Specialist

Electrical/Controls Technician

Production Manager

Associate I, Quality Operations

Specialist, DEA Compliance

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