As a QA Specialist in the Biopharmaceuticals Testing Laboratory (BioCTL), you will ensure full compliance with Quality Management Systems (QMS) and all relevant regulatory standards. Your work will directly support the generation, testing, and approval of laboratory data, playing a key role in the timely release of medicines to the market.
Key Responsibilities
* Review, approve, and issue QC data to support the timely release of medicines.
* Coach and support teams to improve Right First-Time performance.
* Perform document control activities, including controlled printing, reconciliation, and archiving.
* Assist in audit and inspection preparation and participation.
* Author GMP documents and maintain high documentation standards.
* Initiate and participate in quality events, including deviation investigations and change controls.
* Participate in GEMBA walks and process confirmations to drive compliance and efficiency.
Scope & Accountability
* Direct Reports: None
* Indirect Reports: None
* Budget/Revenue Responsibility: N/A
Required Skills & Experience
* Education: Bachelor of Science (or equivalent experience) in Science, Engineering, or a technical discipline.
* Experience: Minimum 2 years previous experience in a regulated environment, ideally GMP, in a Quality or Manufacturing support role. Laboratory experience is advantageous.
* Skills:
* Strong analytical and data interpretation skills.
* Proficiency in Microsoft Office.
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Quality Assurance and Research
Industries
* Pharmaceutical Manufacturing
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