QA Specialist
About the role
Join our dynamic Quality & Compliance team as a QA Specialist, where you will play a pivotal role in maintaining high-quality standards within the biotechnology industry. You will support quality assurance processes, ensure compliance with regulatory standards such as FDA and EMA, and collaborate with cross-functional teams to uphold product integrity and safety. This role demands a strong understanding of laboratory and manufacturing environments. This is a Contract to Hire position based out of Philadelphia, PA with the option to work remotely, primarily during first shift hours. You will collaborate with a team of five within the QMS, including a manager and director, and have significant interaction with Technical Transfer activities. The position is anticipated to close on Oct 26, 2026.
Responsibilities
- Perform batch record review and release in support of US and ex-US clinical trials.
- Investigate and address product quality issues, including deviations, OOS results, and non-conformances.
- Collaborate with CDMOs and internal CMC teams to ensure quality standards are met from development through commercialization.