Investigo is working with an established global biotechnology company who are currently seeking a QA Clinical GMP contractor for a 40 hour per week 6 to 12 month contract. On-site is a must for this role so you must be within a reasonable commute to Wilmington, DE. Option to go contract to hire for those interested.
The role will have a short interview process with an expected start date within December 2022 or January 2023.
This role is intended to ensure that manufacturing; packaging and testing of small molecule products are performed in compliance with GMP requirements, regulatory submissions and procedures.
Essential Functions of the Job (Key responsibilities)
- Review and disposition of suppliers executed drug substance and drug product batches intended for use in clinical studies during clinical development stage. Act as QA lead and single point of contact for managing small molecule products.
- Review and approve supplier GMP documents including, but not limited to master batch records, specifications, test procedures.
- Responsible for suppliers GMP oversight per procedures.
- Perform QA duties during management of supplier quality events such as investigations, change controls, CAPAs and complaints related to clinical development projects.
- Execute QA duties in compliance with Quality Systems, Global policies and procedures.
- Perform internal and external cGMP audits.
- Establish and maintain Quality Agreements with third parties.
- Collaborate effectively with cross-functional teams including but not limited to Analytical Development, Process Chemistry and Pharmaceutical Development.
- Review Regulatory documentation, such as NDAs, INDs and IMPD, as well as responses to Health Authority questions as needed.
- Report and maintain Quality Management System metrics associated with his/her responsibilities, as needed.
- Manage and track controlled document distributions to external CMO's.
- Perform QA role during management of internal Quality Events records in Veeva such as audits, deviations, CAPAs and change controls as needed.
- Provide support and participate in regulatory agency inspections.
- Bachelors degree in scientific/life-sciences or related field.
- A minimum of 5-7 year experience in the Pharmaceutical or Biopharmaceutical industry with at least 5 year experience in a QA function required.
- Experience in managing GMP operations related to small molecule products.
For more informaton on this role, apply via our website.