QC Laboratory Specialist
Job Description:
As a QC Laboratory Specialist, you will play a crucial role in maintaining quality systems, facilitating inter-site qualification, and driving continuous improvement in QC operations while upholding cGMP standards. You will be responsible for managing laboratory standards, controls, and critical reagents, ensuring compliance with regulatory requirements.
Responsibilities:
* Management of standards, controls and critical reagents in the laboratory
* Support with inter-site qualification and extension of controls and standards
* Providing audit support to the team including performing routine and pre-audit walkthroughs, assisting SMEs to prepare and coordination of QC requests during audits
* Reviewing and updating procedures and processes to ensure compliance to current and updated requirements and regulations
* Preparation of qualification memos in electronic systems to support testing activities
* 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 laboratory within the pharmaceutical or biotech industry
* Strong understanding of regulatory guidelines and quality systems
* Experience with laboratory standards, controls, and qualification processes
* Strong communication and organizational skills, with the ability to support audits effectively
* Attention to detail and ability to identify and escalate potential issues promptly
Benefits:
This is an entry-level position that offers the opportunity to work in a dynamic environment and contribute to the success of our organization.