QMS Investigator/Supervisor - Quality Control from Joulé

Title: QMS Investigator/Supervisor - Quality Control
Location: Piscataway, NJ
Duration: Contract to Hire 

• 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.

• 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.