This role is responsible for serving as a quality lead for Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. The Client QA contact serves as the dedicated Client QA Representative and liaisons with the Client and other Paragon functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. This position has the responsibility and authority to review and disposition GMP batches. Responsible for being involved in and providing disposition for failure investigations. Drive continuous quality improvement through communication/training, waste reduction, and mistake-proofing. Responsibilities include providing QA input to technology transfer documents, specifications, master/executed batch records, change requests, deviations and investigations. Shift work and/or weekend work may be required at times.
Key Responsibilities include but are not limited to:
- Provides dedicated QA support to client projects and quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product.
- Primary QA contact during client project lifecycle.
- Responsible for review and approval of master documents supporting the manufacture of products.
- Oversees the coordination and review of executed manufacturing documents, including delivery of such documents to clients.
- Supports and/or leads client on-site audits and participates in on-site technical visits.
- Facilitates resolution to quality issues and interfaces with the client to gain concurrence. Ensures that non-conformances are properly investigated and documented.
- Act as first responder and approval authority for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions.
- Develop standard work practices to ensure high and consistent level of quality is maintained. Provide training in standard work specifics. Support, participate in, and approve compliance critical efforts.
- Lead and participate in site quality and process improvement initiatives to ensure compliance and efficiency.
- Stay current with changes to current Good Manufacturing Practices, including FDA, EU, and other regulatory bodies (relevant to Paragon activities) and guidance bodies including ICH, ISPE, etc.
- Support regulatory (i.e. FDA, EMA) and client audits/inspections of Paragon.
Education & Experience:
- Minimum of a B.S. in a Life Sciences discipline
- +6 years’ experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry
- +6 years’ experience in Quality Assurance/Quality Control function
- Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
- Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines
Requisition ID : 1166