Quality Control Technician I, Laboratory Management

2 weeks ago

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

POSITION SUMMARY

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

KEY RESPONSIBILITIES

  • Execute assigned QC tasks as directed by the supervisor, including:
  • Facilitate the control and management 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 using validated analytical techniques.
  • Perform peer reviews of analytical results to ensure accuracy and compliance.
  • Engage in additional QC duties such as laboratory and equipment upkeep, management of QC documentation, inventory control, coordination with contract laboratories, and reconciliation of sample requests and documentation.
  • Initiate and assist in the resolution of Quality events, including Incident Reports, Deviations, Out of Specification (OOS) results, and Out of Trend (OOT) occurrences.
  • Support administrative and management tasks within the AD/QC laboratory.
  • Contribute to Analytical Development projects and tasks as assigned.
  • Compile and document data for test procedures and report preparation.
  • Assist in the development, transfer, and validation of analytical methods, as well as testing of GMP samples.
  • Contribute to the enhancement of QC systems as directed by the supervisor, including revisions to system or analytical method Standard Operating Procedures (SOPs).
  • Adhere to cGMP practices during all work activities.
  • Work independently with minimal supervision while demonstrating strong teamwork capabilities.
  • Regularly communicate with management regarding the status of testing and projects, seeking guidance as 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 a plus.

KNOWLEDGE, SKILLS, AND ABILITIES

  • Solid understanding of GMP regulations.
  • Experience in sampling and testing within a GMP manufacturing environment.
  • Ability to adapt and thrive in a collaborative, fast-paced setting.
  • Strong attention to detail and organizational skills.
  • Proficient in managing multiple projects and priorities simultaneously.
  • Familiarity with Microsoft Office Suite (Excel, Word, PowerPoint).
  • Effective oral, written, and interpersonal communication skills.

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