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Purpose
The QC Analyst (Controls and Standards) is responsible for managing laboratory standards, controls, and critical reagents, ensuring compliance with regulatory requirements and supporting audit readiness. This role plays a key part in maintaining quality systems, facilitating inter-site qualification, and driving continuous improvement in QC operations while upholding cGMP standards.
Responsibilities
* Management of standards, controls and critical reagents in the QC laboratory
* Support with inter-site qualification and extension of controls and standards
* Providing audit support to the QC team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
* Reviewing and updating QC procedures and processes to ensure compliance to current and updated requirements and regulations e.g. new or updated pharmacopoeia chapters
* Preparation of qualification memos in Veeva to support QC testing activities
* Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means
* Ensure compliance to cGMP at all times
Qualifications
* Bachelor’s degree (or equivalent) in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Science)
* Previous experience in a QC laboratory within the pharmaceutical or biotech industry
* Strong understanding of cGMP requirements and regulatory guidelines
* Experience with laboratory standards, controls, and qualification processes
* Familiarity with quality systems and electronic systems (e.g., Veeva) is an advantage
* Strong communication and organizational skills, with the ability to support audits effectively
* Attention to detail and ability to identify and escalate potential issues promptly
Seniority level
* Entry level
Employment type
* Contract
Job function
* Quality Assurance
Industries
* Pharmaceutical Manufacturing
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