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.