As a QC External Lab Coordinator 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 QC External Lab Coordinator, a typical day might include, but is not limited to, the following:
* 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
* Using our sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to resolve accuracy and to maintain sample integrity
* Working as part of a team to ensure that samples are delivered to the laboratories on-time
* Coordinating the issuance and approval of Quality Agreements with the contract labs. Author Master Service Agreements, as necessary
* Participating as required by QA in GMP audits to the contract labs
* Documenting and communicating discrepancies to appropriate personnel in a timely and efficient manner
* Ensuring that all work carried out is in compliance with the required regulatory standards, conform to company policies and standard operating procedures (SOPs)
* Reviewing and approving method transfer validation protocols and reports
* Assisting the external laboratories in troubleshooting and identifying root cause analysis and providing technical advice as needed
* Conducting laboratory investigations and generating reports in response to invalid assays, Deviations, OOS/OOT
* Initiating and completing CAPAs and Change Controls in accordance with site procedures
This role might be for you if:
* You are a hard-working and innovative problem-solver
* You are team-oriented with strong interpersonal skills
* You are an adaptable continuous learner
To be considered for this role, you must hold a third level qualification (BSc degree or higher) in biology, chemistry, microbiology or 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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