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QC Analyst
2 weeks ago
- Routinely receive manufacturing test samples and distribute to the appropriate analytical laboratories.
- Oversee and maintain procedures ensuring chain of custody for QC samples is preserved.
- Manage the incoming shipment processes from external sites, verify sample inventory, process samples, and distribute to QC test laboratories.
- Ship Drug Product and associated bulk Drug Substance regulatory samples to BOH sites.
- Manage stability sample processes including study enrolment, time-point pulls, sample shipment, and study disposal.
- Maintain the reserve program, inspect reserve and retention samples, document inspection results, and upkeep reserve/retention equipment.
- Inventory management of reference materials.
- Review and approve QCSM standard operating procedures, sampling and analysis plans, and stability protocols.
- Facilitate laboratory investigations and support product investigations.
- Support the preparation and review of QC APQR and periodic review reports.
- Engage with customers and key stakeholders proactively to deliver samples within specified turn-around times, participating in cross-functional teams as needed.
- Represent QCSM at product, technical, and robustness team meetings and take charge of associated deliverables.
- Contribute to complex projects, manage own time to meet targets, and develop plans for work activities within a team.
- Participate in initiatives like 5S, Standard Work, Data Integrity, and IMEX programs as they occur.
- Engage with the business to identify and define scope for continuous improvement, robustness, and Best Practice initiatives, assisting in enhancing efficiency of local and across-site processes and procedures.
- Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), site policies/procedures, and regulatory requirements.
- Perform technical writing assignments such as SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
- Assist in maintaining and developing training programs, and conduct training of other analysts. Report and document any non-conformances to the QC Supervisor.
- Third-level Qualification in Science, Engineering, or related Technical field required.
- Minimum of 4 years' experience in Quality Control or Quality Assurance positions. Experience in Sample Management, Stability Management, Product Inspections, and Lab systems (LIMS, SAP, Trackwise, PDOCs) advantageous.
- Strong communication and interpersonal skills.
- Proven capabilities and experience collaborating and working effectively in team settings; diverse collaboration; stakeholder influence and building business partnerships to drive results.
- Ability to work independently and as part of a team in a dynamic, fast-paced environment. Excellent communication and interpersonal skills.
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