Job Description:
QC External Lab Coordinator
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.
* Key Responsibilities:
* Planning, prioritizing, and coordinating sample management and method transfer activities to external laboratories for a wide variety of microbial and analytical techniques.
* Using our sample tracking system (LIMS) to review sample inventory against samples sent and received by the external laboratories to resolve accuracy and 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 and conforms to company policies and standard operating procedures (SOPs).
* Reviewing and approving method transfer validation protocols and reports.
* Assisting the external laboratories in troubleshooting, 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.
Requirements:
* 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 a related field with relative experience (preferably in the pharmaceutical or biotechnology industries). Relevant work experience may substitute for the degree requirement.