The QC Records Investigator plays an important role in the department by leading QC deviations, participating in delegating tasks/new deviations to investigators, setting timelines and tracking all open items to ensure deadlines are being met. The QC Records Investigator is required to also communicate with internal stakeholders/SME and client for updates and working sessions. The QC Records Investigator is expected to assist the team members in conducting Root Cause Analysis (RCA) and ensuring adequate CAPAs are being initiated to mitigate issues. In addition, the QC Records Investigator will act as a point of contact between the Operations group, QA/client QA and regulatory agencies.
- Delegates tasks to investigators, sets timelines and tracks all open items to ensure deadlines are being met.
- Ensures investigators are adequately conducting RCA and CAPAs to mitigate issues identified while conducting investigations.
- Authors deviations to determine adequate RCA and CAPAs for Operations including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and ensuring batch release items are closed on time to meet company targets.
- Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.
- Ensures the departments stays in compliance (manages extensions when needed)
- Actively participates in regulatory, client and internal audits by compiling and providing information to department manager.
- Sets monthly DR closure timelines and ensures Deviations are closed within assigned timelines to meet client demand and company targets.
- Attend daily Operations meetings and communicate progression of open deviations to Stakeholders.
- Participates in data gathering and analysis for Monthly and Quarterly quality matrix and departmental KPI.
- Ensures adherence to GDP, GMP, and safe practices at clinical and commercial scales.
- Implement process improvement related changes.
- Provide support in ensuring batch readiness action items are completed prior to batch start
- Performs all other job-related duties as assigned
- Bachelors Degree in related field with relevant industrial experience in pharmaceutical practices.
- Demonstrate ability to perform RCA investigations and lead CAPA initiatives.
- Demonstrate ability to review manufacturing, engineering, and quality documentation.
- 5-8 years of strong working knowledge of GMP requirements.
- Experience in top-tier biopharmaceutical environment
Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target annualized base pay hiring range for this position is $103,000.00 - $130,000.00. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate’s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.