Job Title: Quality Assurance Specialist
This is a high-performing, fast-paced sterile manufacturing opportunity to work in a dynamic team environment supporting production teams across multiple shifts.
Key Duties & Responsibilities:
* Provide day-to-day quality support to production teams ensuring compliance with GMP standards and site procedures.
* Perform timely review and approval of batch documentation including line clearance verification.
* Assist in investigations of deviations customer complaints and unplanned events using systems such as TrackWise.
* Conduct and report on routine audit readiness and quality metrics to drive continuous improvement and maintain compliance.
* Participate in spot-checks and walkthroughs on the production floor to monitor adherence to quality standards.
* Ensure compliance with current GMP FDA EMA and internal quality standards and regulations.
* Liaise with cross-functional teams Manufacturing Engineering QC to identify and implement quality improvements.
* Utilize computerized systems for recording tracking and reporting quality-related activities.
* Maintain awareness of industry trends and regulatory updates relevant to sterile manufacturing.
A Bachelors degree or higher in a Science related discipline is required. 12 years experience in a QA role within a pharmaceutical manufacturing environment ideally with aseptic/sterile processing exposure is desired.
Why This Role?
Gain valuable experience in a sterile manufacturing environment working on a flexible shift pattern. Be part of a collaborative team environment with opportunities to develop professionally.