Be a part of a team dedicated to making a difference. Use your expertise to empower scientists around the world to advance clinical drug development and create a meaningful impact on healthcare. AnaSpec is a CDMO (contract development and manufacturing organization) that manufactures research-use to GMP grade peptides, peptidomimetics and dyes, with operations based in Fremont, California. Our GMP grade peptides are used to support preclinical studies and clinical applications.

The QC Method Validation Specialist role is integral to our GMP operations and among other things, will perform tasks associated with stability programs, purity method development (including forced degradation studies to establish stability indicating method) as well as phase appropriate validation.

Position:

The QC Method Validation Specialist leads project tasks and activities associated with analytical method qualification, validation, and verification. Specific activities include preparation, execution and review of protocols and reports associated with analytical method development, qualification and validation. You will be responsible for participating in laboratories' readiness for routine testing of clinical phase GMP products, H/UPLC Purity Method development and validation.

Responsibilities:

  • Leads project with minimal supervision, manage project timelines and deliverables.
  • Drives continuous improvement; represent QC (analytical H/UPLC purity method development and validation) on cross functional teams; and providing guidance and training to other team members; troubleshooting.
  • Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
  • Coordinates action plans and contributes toward team and project goals.
  • Interacts with clients, presents data to clients as group representative, independently on occasion and with minimal supervision.
  • Review and authorize all laboratory data and have extensive overall knowledge of all laboratory operations.
  • Create, review, and approve compliant test method development and validation protocols and reports.
  • Implement statistical tools, root cause analysis methodologies, etc.
  • Train and assist team members. Create an environment knowledge-sharing so everyone on the team learns and grows with the Company.
  • Produce and maintain good written documentation of experiments.
  • Participate actively in joined projects.
  • Ensure implementation, compliance, and continuous improvement of QMS through SOP documentation.
  • Other duties as assigned by Management.

 

Requirements:

  • BS or BA degree in science or related field required.
  • At minimum 2-3 years of experience in quality in the biotech or pharmaceutical, or highly regulatory industry required.
  • Experience in Quality Control required.
  • Experience in laboratory practices, comprehensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories and working experience with a wide range of analytical techniques, analytical testing and use of analytical equipment required.

Join the AnaSpec team, where your career growth and well-being come first! We’re an equal opportunity employer dedicated to fostering a supportive, inclusive workplace. We offer a competitive compensation package and a full suite of benefits, including comprehensive medical, dental, and vision coverage, flexible spending accounts, life and disability insurance, gym reimbursement and more. Use your skills to make a lasting difference for a better tomorrow and launch the next phase of your career with AnaSpec.

Salary range: $85-100K negotiable.

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