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 memo's 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
* Preparation of qualification memo's in Veeva to support QC testing activities
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.