Job Description
- Process document control requests and issue-controlled forms, logbooks, notebooks, master production records, labels, and protocols.
- Reconcile issued controlled forms, logbooks, notebooks, master production records, and protocols.
- Coordinate and facilitate QA-related production and production-related activities.
- Review batch-related documentation and ensure resolution of issues to release product.
- Ensure that products are manufactured in compliance with site procedures, regulatory and cGMP guidelines.
- Compile and verify all batch-related documents into a final product lot disposition package.
- Communicate lot disposition pending issues to management.
- Review qualification / validation protocols and reports and ensure resolution of and discrepancies that occurred during execution.
- Control document lifecycle activities, including biennial review of procedures and document retention for select SOPs.
- Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.
- Work with the Manufacturing, Quality Control, Assay Development, and Process Development departments as a production area Quality Assurance representative. Key areas of collaboration include but are not limited to; calibration and preventive maintenance process monitoring and inventory control monitoring.
- Support regulatory inspections as needed.
- Enhance skills via regular training and continuing education, including professional society membership/participation.
- Completion of gowning qualification and maintaining status for entry into Aseptic processing area. Must be able to demonstrate a sound knowledge of aseptic gowning practices.
- Author, Approve or Authorize documents as assigned. Documents include but are not limited to: Master Production Records, Quality Control test methods/forms, Method Qualification/Validation records, etc. Authorization includes a review of the content for applicability in connection with customer audit/inspections as well as GMP compliance.
- Perform other duties as required.
- Minimum of a Bachelor’s degree in related field and/or equivalent experience.
- Minimum of 1 – 5 years of experience in quality and/or manufacturing in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.
- Working knowledge of quality systems and ability to apply cGMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
- General knowledge of aseptic manufacturing processes.
- Excellent organizational skills, attention to detail, and Good Documentation Practices.
- Proficiency in MS Word, Excel, Power Point, Microsoft Office 365 and other applications.
- Must possess effective interpersonal, verbal, and writing skills, patience, professionalism, and the ability to effectively interact and communicate with internal staff and management.
- Comfortable in a fast-paced, patient-focused manufacturing environment with minimal direction and able to adjust workload based on changing priorities.
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