Quality Control Investigation Writer

How you’ll make an impact:

We seek an experienced QC Investigator to manage deviations in our growing commercial-level in-house GMP testing groups to support in-process, release and stability deviations for multiple stages of our gene therapy and immune oncology products. This includes investigation, drafting, data review/release and trending of our analytical test methods and GMP operational support systems ensuring a compliant Quality Control lab.

About the team:

You will interface with multiple Quality Control and Quality Assurance functions in support of investigative activities. In addition will collaborate with, IT, Manufacturing, Facilities, and other cross-functional teams as required. A strong cGMP, operational and technical background in cell biology, biochemistry, and/or molecular biology will be utilized in the role. Collaborate internally and externally leading investigations focused in testing of analytical, cell-based, and immunological-based test methods

How you’ll spend your time:

• Gather and analyze critical data generated by Quality Control testing laboratory (raw data, calculations, data trend study) and review
• Review Test methods and Laboratory data and/or LIMS for accuracy
• Analyze instrument and reagent performance and previous failures to support investigations
• Maintain and log laboratory investigations to track the completion of the quality events
• Conduct personnel interviews and system reviews as a part of investigation
• Observe analytical testing for investigations
• Prepare investigation reports as per standard operating procedures and FDA guidelines and confirm applicable approvals
• Compile documentation from laboratory to support investigations and quality events as needed
• Determine conclusions based on the analysis of the data, prepare investigation reports, and assign effective CAPAs
• Summarize and complete the laboratory investigation with a scientific, assignable root cause.
• Assure timely closure of investigations, CAPAs, assist in performing effectiveness checks
• Review records to ensure meets the industry requirements for data integrity - resolve any discrepancies
• Ensure procedures are followed as outlined per FDA, ICH, Standard Methods, SOPs, and the Quality Systems’ requirements
• Uses 5-WHY, Ishikawa Diagram and other Root Cause Analysis tools to structure and aid problem solving activities within a cross-functional team determining appropriate corrective/preventative actions as a result of investigation findings.
• Reviews and approves Certificate of Analysis and other relevant documents
• Evaluation, task managements and approval Change Control Requests for Materials.

Who you are and what you’ve accomplished:

• Bachelors or Masters’ degree in Chemistry/pharmaceuticals sciences/Biology/Life Science or any other relevant degree.
• 7+ years proven experience in pharmaceutical industry; QA/QC background preferred.
• Demonstrates a high degree of attention to detail, with strong documentation expertise. Able to effectively multi-task and demonstrate strong organizational skills.
• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.
• Demonstrated background in core QMS concepts and QMS improvement activities.
• Proficient using computerized systems, including Microsoft Office applications.
• Act as a Subject Matter Expert on written deviations during regulatory and internal audits.