System One
QMS Investigator/Supervisor - Quality Control
System One, Piscataway, New Jersey, United States,
Title: QMS Investigator/Supervisor - Quality ControlLocation: Piscataway, NJDuration: Contract to Hire
Requirements:Bachelor’s Degree in Chemistry/Molecular Biology or Cell Biology with 12+ years of experience.M.S. in Chemistry/Biology, Molecular Biology, with 8+ years of industry experience or relevant experience in QC or equivalent experience in Pharmaceutical/Biopharmaceutical industry.Knowledge and experience in cGMP in Pharmaceutical/Biopharmaceutical industry.Positive attitude, ability to work with a team to resolve problems in a timely manner, and lead the team to meet organizational goals.Experience with Inspection Readiness for Commercial and PAI Internal/External Auditing and Presentation Skills is required.A good working knowledge of global GxP compliance is preferred.Excellent time and project management skills under competing priorities are required.Responsibilities:Support Quality Control operations under the direction of Quality Control leadership, including:Conduct all analytical testing activities on time to meet project timelines in a GMP environment.Demonstrate chain of custody of samples received in QC, plan for testing, and report results in a timely manner.Schedule QC analysts' weekly plans for timely sample testing.Ensure QC analysts complete documentation concurrently while performing tests in real time.Author, review, and revise technical documents (protocols, specifications, reports, SOPs, test methods, memos, and Impact Assessments) in coordination with AR&D and Regulatory.Work with CMC and regulatory to author Analytical and Stability sections for IND/BLA/MAA filings/amendments.Conduct laboratory investigational experiments and write thorough investigations with scientific justification and root cause analysis.Review equipment calibration, validation, and maintenance records to ensure timely and correct performance.Schedule analytical data review and timely release of materials, acting as a peer reviewer as required.Ensure all testing activities meet cGMP requirements, including procedures and policies.Optimize, validate, and execute transfer of cell-based assays from R&D and/or external laboratories to QC lab.Operate microbiological or analytical instrumentation (HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, VHP Isolator, Plate Reader, etc.) during service activities.Perform various laboratory techniques including q-PCR and/or ELISAs and other techniques.Assist in the creation and closure of Change Control records.Assist in the purchasing of laboratory equipment.Perform Internal Calibration of Equipment as needed.Perform quality testing; review QC data, release testing data, prepare Certificates of Analysis for release of Drug Substance, Drug Product, and other Materials.Prepare and maintain Quality records for review of completeness and accuracy to meet internal and external regulatory compliance.Train and assist Junior QC associates in their functions and assist others as needed.Maintain quality metrics for stability testing adherence.Periodic review of Instrumental SOPs and update as per schedule.Understand basic problem-solving skills, including statistical analysis, and use these tools for root cause identification and problem solving.Initiate OOS/Out-Of-Trend (OOT)/Lab incidents and complete investigation reports in a timely manner.Engage and collaborate with cross-functional internal teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs).Ensure Internal and External Audits are planned and executed based on approved audit schedules.Ensure assigned Internal Quality Events (Deviations, Investigations, CAPAs, OOSs, Laboratory Events, and Effectiveness checks) are completed on time.
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Requirements:Bachelor’s Degree in Chemistry/Molecular Biology or Cell Biology with 12+ years of experience.M.S. in Chemistry/Biology, Molecular Biology, with 8+ years of industry experience or relevant experience in QC or equivalent experience in Pharmaceutical/Biopharmaceutical industry.Knowledge and experience in cGMP in Pharmaceutical/Biopharmaceutical industry.Positive attitude, ability to work with a team to resolve problems in a timely manner, and lead the team to meet organizational goals.Experience with Inspection Readiness for Commercial and PAI Internal/External Auditing and Presentation Skills is required.A good working knowledge of global GxP compliance is preferred.Excellent time and project management skills under competing priorities are required.Responsibilities:Support Quality Control operations under the direction of Quality Control leadership, including:Conduct all analytical testing activities on time to meet project timelines in a GMP environment.Demonstrate chain of custody of samples received in QC, plan for testing, and report results in a timely manner.Schedule QC analysts' weekly plans for timely sample testing.Ensure QC analysts complete documentation concurrently while performing tests in real time.Author, review, and revise technical documents (protocols, specifications, reports, SOPs, test methods, memos, and Impact Assessments) in coordination with AR&D and Regulatory.Work with CMC and regulatory to author Analytical and Stability sections for IND/BLA/MAA filings/amendments.Conduct laboratory investigational experiments and write thorough investigations with scientific justification and root cause analysis.Review equipment calibration, validation, and maintenance records to ensure timely and correct performance.Schedule analytical data review and timely release of materials, acting as a peer reviewer as required.Ensure all testing activities meet cGMP requirements, including procedures and policies.Optimize, validate, and execute transfer of cell-based assays from R&D and/or external laboratories to QC lab.Operate microbiological or analytical instrumentation (HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, VHP Isolator, Plate Reader, etc.) during service activities.Perform various laboratory techniques including q-PCR and/or ELISAs and other techniques.Assist in the creation and closure of Change Control records.Assist in the purchasing of laboratory equipment.Perform Internal Calibration of Equipment as needed.Perform quality testing; review QC data, release testing data, prepare Certificates of Analysis for release of Drug Substance, Drug Product, and other Materials.Prepare and maintain Quality records for review of completeness and accuracy to meet internal and external regulatory compliance.Train and assist Junior QC associates in their functions and assist others as needed.Maintain quality metrics for stability testing adherence.Periodic review of Instrumental SOPs and update as per schedule.Understand basic problem-solving skills, including statistical analysis, and use these tools for root cause identification and problem solving.Initiate OOS/Out-Of-Trend (OOT)/Lab incidents and complete investigation reports in a timely manner.Engage and collaborate with cross-functional internal teams to evaluate processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company Standard Operating Procedures (SOPs).Ensure Internal and External Audits are planned and executed based on approved audit schedules.Ensure assigned Internal Quality Events (Deviations, Investigations, CAPAs, OOSs, Laboratory Events, and Effectiveness checks) are completed on time.
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