QC Associate I, Lab Control
1 week ago
We are seeking a highly motivated and detail-oriented Quality Control Associate I, Lab Control to join our Analytical Development (AD) / Quality Control (QC) team at Tanvex Biopharma USA Inc. The successful candidate will be responsible for supporting the control and management of samples within QC and performing routine testing of in-process, release, and stability samples following written methods and procedures.
Key Responsibilities- Perform routine QC responsibilities as assigned by supervisor, including receiving, aliquoting, and processing samples within QC.
- Conduct routine and non-routine analyses of GMP product and raw material as assigned using appropriate analytical methods.
- Perform peer review of test results.
- Support laboratory and equipment maintenance, QC document management, QC inventory control, contract lab coordination, and reconciliation of sample requests/documents as needed.
- Initiate and assist in the closure of Quality events (Incident Reports, Deviations, OOS's, OOT's etc.).
- Support AD/QC lab management and administrative tasks.
- Assist in Analytical Development tasks and projects as assigned.
- Compile data for documentation of test procedures and preparation of reports.
- Assist in assay development, transfers, validation of analytical methods, and testing product GMP samples as assigned.
- Assist in improving QC systems as assigned by supervisor, including revising system or analytical method SOPs.
- Education and Experience:
- BS or advanced degree in chemistry, biology, biochemistry or related life sciences discipline.
- BS with 0-3 years' experience in Quality Control within GMP biopharmaceutical or biotechnology industry. Experience with regulatory compliance inspections is desirable.
- Knowledge, Skills and Abilities:
- Working knowledge of GMP regulations.
- Experience with sampling and testing in a GMP manufacturing facility.
- Ability to adapt, work flexibly, and thrive in a highly collaborative environment.
- Ability to work in a fast-paced, start-up environment.
- Strong attention to detail.
- Capable of being organized and managing multiple projects and responsibilities simultaneously.
- Ability to manage multiple projects and priorities, good organizational and problem solving skills.
- Knowledge of Microsoft Office suite (Excel, Word, PowerPoint).
- Good oral, written, and interpersonal communication skills.
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