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Quality Control Specialist I, Laboratory Management

2 months ago

San Diego, California, United States TANVEX BIOPHARMA USA INC Full time
Position Overview

SUMMARY

The Quality Control Specialist I, Laboratory Management plays a crucial role in overseeing the management and control of samples within the Quality Control (QC) department. This position involves executing routine testing of in-process, release, and stability samples in accordance with established protocols and procedures. The individual will collaborate closely with the Analytical Development (AD) and Quality Control (QC) teams to fulfill departmental responsibilities while adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

KEY RESPONSIBILITIES

- Execute routine QC tasks as directed by the supervisor, including:

- Facilitate the management and control of samples by receiving, aliquoting, and processing them within the QC framework.

- Conduct both routine and non-routine analyses of GMP products and raw materials as assigned, utilizing appropriate analytical techniques.

- Perform peer reviews of analytical results to ensure accuracy and compliance.

- Additional responsibilities encompass laboratory and equipment upkeep, management of QC documentation, inventory control, coordination with contract laboratories, and reconciliation of sample requests and documents as necessary.

- Initiate and assist in resolving Quality events, including Incident Reports, Deviations, Out of Specification (OOS) results, and Out of Trend (OOT) findings.

- Support administrative tasks related to AD/QC lab management.

- Assist in Analytical Development projects and tasks as assigned.

- Compile and document data for test procedures and prepare comprehensive reports.

- Aid in the development, transfer, validation of analytical methods, and testing of GMP samples as required.

- Contribute to the enhancement of QC systems as directed by the supervisor, including revisions to system or analytical method Standard Operating Procedures (SOPs).

- Apply cGMP practices diligently during all work activities.

- Work autonomously with minimal supervision while demonstrating strong teamwork capabilities.

- Regularly communicate the status of testing and projects to management and seek guidance when necessary.

EDUCATION AND EXPERIENCE

- Bachelor’s degree or higher in Chemistry, Biology, Biochemistry, or a related life sciences field.

- Bachelor’s degree with 0-3 years of experience in Quality Control within the GMP biopharmaceutical or biotechnology sector. Familiarity with regulatory compliance inspections is advantageous.

KNOWLEDGE, SKILLS, AND ABILITIES

- Proficient understanding of GMP regulations.

- Experience in sampling and testing within a GMP manufacturing environment.

- Ability to adapt and thrive in a collaborative and dynamic setting.

- Capability to function effectively in a fast-paced, start-up atmosphere.

- Strong attention to detail and organizational skills.

- Competence in managing multiple projects and priorities simultaneously.

- Familiarity with Microsoft Office Suite (Excel, Word, PowerPoint).

- Excellent oral, written, and interpersonal communication skills.