Quality Control Specialist I, Laboratory Management

1 week ago

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

POSITION 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 conducting routine analyses of in-process, release, and stability samples in accordance with established methods and protocols. The role is integral to the Analytical Development (AD) and Quality Control (QC) teams, ensuring compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

KEY RESPONSIBILITIES

  • Execute routine QC tasks as directed by the supervisor, including:
  • Manage and control samples by receiving, aliquoting, and processing them within the QC framework.
  • Perform both routine and specialized analyses of GMP products and raw materials using appropriate analytical techniques.
  • Conduct peer reviews of analytical results to ensure accuracy and compliance.
  • Engage in additional QC duties such as laboratory maintenance, documentation management, inventory control, and coordination with contract laboratories.
  • Initiate and assist in resolving Quality events, including Incident Reports, Deviations, Out of Specification (OOS) results, and Out of Trend (OOT) findings.
  • 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 GMP samples.
  • Support enhancements to QC systems as directed by the supervisor, including revisions to standard operating procedures (SOPs).
  • Adhere to current cGMP practices throughout all work activities.
  • Work independently with minimal supervision while demonstrating strong teamwork capabilities.
  • Regularly communicate the status of testing and projects to management, seeking 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

  • Comprehensive 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.
  • Capability to manage multiple projects and priorities effectively.
  • Proficient in Microsoft Office applications (Excel, Word, PowerPoint).
  • Excellent oral, written, and interpersonal communication skills.

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