Within this role you will perform sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
As a Temp QC External Lab Coordinator, a typical day might include, but is not limited to, the following:
1. Planning, prioritising and coordinating sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques to support raw material, utilities, in-process and bulk drug substance manufacture in a cGMP regulatory environment.
2. Using our sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to determine accuracy and to maintain sample integrity.
3. Working as part of a team to ensure that samples are delivered to the laboratories on-time.
4. Coordinating the issuance and approval of Quality Agreements with the contract labs and author Master Service Agreements, as necessary.
5. Participating as required by QA in GMP audits to the contract labs.
6. Documenting and communicating discrepancies to appropriate personnel in a timely and efficient manner.
7. Ensuring that all work carried out is in compliance with the required regulatory standards, and conforms to company policies and standard operating procedures (SOPs).
8. Reviewing and approving method transfer validation protocols and reports.
9. Assisting the external laboratories in troubleshooting and identifying root cause analysis to provide technical advice as needed.
10. Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT.
11. Initiating and completing CAPAs and Change Controls in accordance with site procedures.
This role might be for you if:
1. You have a proven ability to work independently or as part of a team.
2. You possess strong trouble-shooting and problem solving skills.
3. You have strong attention to detail & excellent written and oral skills.
To be considered for this role, you must hold a third level qualification (BSc degree or higher) in biology, chemistry, microbiology or a related field with relative experience (preferably in the pharmaceutical or biotechnology industries). Will substitute relevant work experience in lieu of degree requirement.
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