Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

Quality Control Supervisor

Scheduling & Production Planning Analyst

Lead Quality Specialist - Investigator

Manufacturing Operator II

Reliability Technician

QC Chemist I

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</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></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <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>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities 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><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</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>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</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>

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>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>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>

Responsibilities:The Technician III, Reliability performs facility reliability maintenance activities in accordance with approved procedures requiring limited supervision. Proficient at analyzing and troubleshooting the root cause of facility, manufacturing and packaging equipment problems. Implements effective preventive and/or corrective maintenance repairs to provide increased reliability. Identifies maintenance improvements that increase efficiency, throughput, and quality. May train others in setting up equipment. Identifies and solves complex problems. Understands the practical application to problems and situations ordinarily encountered and makes decisions that require choosing from several options.Requirements:May be required to be proficient in troubleshooting & repair in 4 or more of the following areas:ElectricalHydraulicsPneumaticsMechanicalPLC'sProficient in following areas:Ability to read and follow blueprints and engineered drawings.Ability to use theBMS (Bldg. Management System) for HVACSpecialized in at least 4 of the following 5 areas:Utility – purified water systems, compressed air, boiler, chilled water, electrical distribution, product dust collection systems.Building Maintenance – sewers, electronic card readers (when applicable), lighting.Fire suppression systems.HVAC competence and certification, as required.General building & grounds maintenance.Basic math, writing skills, problem solving.Basic computer skills.Ability to use hand tools.Control Precision - ability to quickly and repeatedly adjust the controls of a machine to exact positions.Basic math, writing skills, problem solving.Education & Experience:A High School Diploma or equivalent is required.Level 3 TechSeven years related experience and certification in assigned area(s), as required.ACCP-Level II Certification or equivalent experience

Responsibilities:The Chemist I, under direct supervision, learns and performs QC laboratory chemical analyses of raw materials, in-process materials, stability and finished products, and testing to support process validation.May participate in investigations.Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.Conducts routine laboratory analyses: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.Typical activities may include buffer/solution preparation, standard preparation and operating analytical instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses.Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeepingCleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.Under close supervision, learns to troubleshoot basic instrument problems.With guidance, participates in OOS/OOT/NOE and other investigations.Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor.May assist in drafting, editing, and reviewing SOPs and laboratory investigations.Maintains assigned training records current and in-compliance.May assist in the training of less senior laboratory staff.Performs assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.Follows internal processes related to controlled substances continuous.Follows EH&S procedures to ensure a safe work environment.Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS continuous.Requirements:Minimal acceptable level of education, work experience and certifications required for the job.Bachelor of Science Degree in chemistry, chemical engineering or related field with analytical chemistry coursework required. Some pharmaceutical laboratory experience preferred.Proficiency in a body of information required for the job.e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.Proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Basic knowledge of wet chemistry techniques.Knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.Competency in Microsoft Office Suite.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.Ability to display and analyze data in a logical manner.Good verbal and written communication skills as well as good computer skills.Attention to details and accurate record keeping.Establish and maintain cooperative working relationships with othersSolid organizational skills.Ability to take initiative, set priorities and follow through on assignments.Physical & mental requirements e.g., lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicalsMust occasionally lift and/or move up to 15-25 lbs.Ability to wear personal protective equipment, including respirators, gloves, etc. Specific visions abilities are required by this job include close vision and color vision.Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.

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8 chestnut ridge Jobs found

Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

Quality Control Supervisor

Scheduling & Production Planning Analyst

Lead Quality Specialist - Investigator

Manufacturing Operator II

Reliability Technician

QC Chemist I

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8 chestnut ridge Jobs found

Site Investigation Lead, Quality Assurance

Digital Marketing Specialist

Quality Control Supervisor

Scheduling & Production Planning Analyst

Lead Quality Specialist - Investigator

Manufacturing Operator II

Reliability Technician

QC Chemist I

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