Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to join a team in a GMP and ISO-certified manufacturing setting. This is an exciting opportunity to be part of a fast-paced, growing operation that supports the bio/pharmaceutical industry with high-quality Single Use Technology products.
Reporting to the Quality Manager, you will work collaboratively across teams to maintain and enhance our quality systems. The role plays a vital part in ensuring that all products meet internal and external specifications, supporting operational compliance, and upholding product safety and integrity.
Key Responsibilities
* Perform in-process quality inspections on components, finished assemblies, and packaging within an ISO 7 Class cleanroom.
* Conduct real-time batch record reviews.
* Ensure ongoing compliance of critical equipment through verification, calibration, maintenance, and qualification.
* Investigate and document non-conformances, implementing corrective and preventative actions.
* Contribute to quality system activities including document drafting and timely execution.
* Maintain and update quality management system (QMS) logs and tracking tools.
* Conduct routine environmental monitoring activities.
* Support internal and external audit processes.
* Participate in continuous improvement initiatives.
* Deliver and receive training on quality-related processes.
* Perform other quality-related tasks as required.
Qualifications & Experience
* Minimum of 3 years’ experience in a quality function within a GMP/regulatory environment.
* Background in bio/pharmaceutical, medical device, nutraceutical, or food science industries is preferred.
* Strong attention to detail, proactive mindset, and ability to work collaboratively in a regulated setting.
#J-18808-Ljbffr