QMS Investigator/Supervisor - Quality Control

Title: QMS Investigator/Supervisor - Quality Control Location: Piscataway, NJ Duration: 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 of relevant experience in QC or equivalent experience in Pharmaceutical/Biopharmaceutical industry. Having the cGMP knowledge and experience in Pharmaceutical/Biopharmaceutical experience. Candidate should be a positive attitude, work with team to resolve the problems timely manner and lead the team to meet the organization 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 is required. Responsibilities: Under the direction of Quality Control leadership, the Supervisor will support Quality Control operations, which includes following essential duties and responsibilities: Conduct all the analytical testing activities on time to meet the timelines as per the Project requirements in GMP environment. Demonstrate chain of custody of samples received in QC, plan for testing, and result reporting in a timely manner to meet deadlines. Schedule QC analysts weekly plan for samples to be tested on time. 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 Assessment) in coordinating with the AR&D and Regulatory. Work with CMC and regulatory as needed to author Analytical and Stability sections for IND/BLA/MAA filings/amendments. Conduct the laboratory investigational experiments and write thorough investigations with scientific justification with root cause analysis. Review equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time. Schedule the analytical data review and release the materials on time, act as a peer reviewer as and when required. Ensure that all testing activities meet cGMP requirements, including the procedures and policies Optimize, validate, and execute transfer of cell-based assays from R&D and/or external laboratories to QC lab. Operating microbiological or analytical instrumentation such as HPLC, GC, UV, ICP-MS, FTIR, TOC, CE, ICE, Karl Fisher, VHP Isolator, Plate Reader Etc. during service activities. Perform various laboratory techniques that include 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 the Internal Calibration of Equipment’s as needed. Perform quality testing; Review QC data, release testing data, Prepare Certificate 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 both 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 SOP’s and update as per the schedule. Understanding of basic problem-solving skills, including statistical analysis, and ability to use these tools to drive 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) as appropriate. Ensure Internal and External Audits are planned and executed based on approved audit schedules. Ensure assigned Internal Quality Events such as Deviations, Investigations, CAPAs, OOS’s, Laboratory Events and Effectiveness checks were completed on time as per timelines.