Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to support our laboratory setup, conduct essential testing, and ensure compliance with cGMP standards.
* Support laboratory setup and equipment qualification.
* Prepare and review laboratory procedures, protocols, and reports.
* Perform QC testing in line with SOPs, cGMP, and regulatory requirements.
* Conduct method verification, validation, and technical transfers.
* Manage laboratory consumables and ensure proper tracking.
* Assist in regulatory audits and maintain audit readiness.
* Collaborate with cross-functional teams, including technicians, operations, and warehouse staff.
* Maintain compliance with Good Documentation Practice (GDP) and Quality Management Systems (QMS).
* Ensure EHS standards are upheld in the laboratory.
To be successful in this role, you will have a degree in Chemistry, Biochemistry, Pharmaceutical Science, or related field, experience in a cGMP-regulated QC or ARD laboratory, and strong understanding of method validation, technical transfer, and regulatory compliance.
We offer a competitive salary & annual bonus, flextime options for work-life balance, Laya Healthcare for employee, partner & dependents, 5% employer-matched pension plan, educational assistance & career development support.