Senior Quality Engineer

Senior Quality Engineer

Responsibilities:
- Implement and maintain the effectiveness of the Quality System.
- Ensure quality goals are met and practices/procedures comply with company policies and applicable regulations for quality areas under responsibility.
- Ensure investigations of plant events are thorough, accurately documented, and included in the plant CAPA system; perform product impact analyses and place product on QA hold where appropriate.
- Maintain effective liaison with other Quality areas and Plant departments.
- Participate on the Validation Review Board as the Manufacturing Quality Assurance function.
- Approve standard operating procedures to ensure they comply with policy.
- Approve calibration requests and ensure appropriate product/process limits are assigned.
- Audit commissioning and validation documentation.
- Develop product quality plans and systems (product/quality specifications, quality plans, risk analyses, FMEAs); develop/implement statistical quality programs and process monitoring systems.
- For specific U.S. manufacturing sites, perform batch release.

Qualifications:
- Bachelor’s degree, preferably in Biology, Chemistry, or Engineering.
- 6+ years of experience in Manufacturing, Quality, or Engineering.
- Good verbal and written communication skills.
- Strong problem-solving and analytical skills.
- Strong interpersonal/comms skills.
- Good negotiation skills.
- Knowledge of quality/compliance management and regulations/standards affecting API, Bulk Drug, or Finished goods manufacturing.