Senior Quality Control Analytical Specialist

2 weeks ago

Mountain View, California, United States ESR Healthcare Full time

Position Title: Senior Quality Control Analytical Specialist

Location: Mountain View, CA

Required Skills: Quality Control Analytical, CGMP, GTP, CAPAs

Experience Level: Mid-senior

Experience Required: 5 Years

Education Level: Bachelor's Degree

Job Function: Quality Control

Industry: Biotechnology

Compensation: View salary

Total Positions: 1

Visa Requirements: Only US citizens and Green Card holders

Job Overview:

At ESR Healthcare, we are committed to pioneering advancements in cell and gene therapy. As a prominent global contract development and manufacturing organization, we recognize the transformative potential of these therapies and are dedicated to shaping the future of medicine.

The Senior Quality Control Analytical Specialist plays a crucial role in supporting both clinical and commercial production. This position involves assisting with process checkpoints, stability assessments, and release analytical testing to ensure that all products meet the highest quality standards.

Key Responsibilities:

  • Execute all company and client testing methodologies for cellular products to ensure safety and efficacy.
  • Maintain, monitor, and troubleshoot essential laboratory equipment.
  • Train and mentor junior Quality Control Analytical Associates.
  • Document and manage training records in collaboration with Document Control and Training teams.
  • Conduct testing, documentation, and reporting of results in compliance with CGMP and GTP guidelines.
  • Participate in proficiency testing as required.
  • Manage quality control materials and supplies efficiently.
  • Assist in the qualification and validation of equipment and methods.
  • Prepare reagents and media as necessary.
  • Lead investigations into non-conforming test results and implement corrective actions.
  • Document and track deviations, Change Controls, and CAPAs.
  • Communicate effectively with colleagues, management, and clients.
  • Contribute to client projects as a lead or co-lead.
  • Ensure compliance with inspection readiness and participate in audits.
  • Collaborate with internal departments and external partners to meet project timelines.

Qualifications:

A Bachelor's degree in a scientific discipline is required, with a Master's degree preferred. Candidates should have prior experience in a CGMP environment, particularly in quality control laboratories, clinical laboratories, microbiology, hematology, blood banking, or immunology. A minimum of 4-6 years of relevant experience in the biopharmaceutical industry is essential.

Competencies:

Proficiency in Microsoft Office and Visio is required. Strong written and verbal communication skills are essential, along with the ability to work collaboratively in a team-oriented environment. Candidates should be detail-oriented, capable of multitasking, and adaptable to the evolving needs of the organization.

Working Environment:

This role may involve exposure to infectious materials and requires adherence to universal precautions. The work environment may include exposure to gases and chemicals, and candidates should be prepared to work in a moderately noisy laboratory setting.

Physical Requirements:

The Senior Quality Control Analytical Specialist must be able to work in a laboratory for extended periods and perform various physical tasks, including standing, walking, and handling laboratory equipment.

Note: This job description is not exhaustive and may be subject to change at any time.

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