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Gmp Quality Control Jobs in California (NOW HIRING)

AllSTEM Connections

Quality Control Analyst I

Camarillo, CA · On-site

$82K - $86K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

... GMP procedures accurately • Ability to work independently and manage routine laboratory tasks ... QC laboratory or pharmaceutical industry experience preferred) • Previous experience in a fast ...

Codexis

Sr. Scientist, Quality Control

Redwood City, CA

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Sr. Scientist in Quality Control will be leading analytical method transfer and validation for ... Strong scientific judgment and analytical problem-solving skills GMP quality mindset with a focus ...

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Gmp Quality Control information

Is GMP quality control inspection a good career?

GMP quality control inspection is a stable career in the pharmaceutical and biotech industries, focusing on ensuring products meet regulatory standards. It often requires attention to detail, knowledge of Good Manufacturing Practices, and certifications such as GMP training. The role offers opportunities for advancement and consistent employment in regulated environments.

What is the role of quality control in GMP?

In GMP, quality control (QC) is responsible for testing and verifying raw materials, in-process samples, and finished products to ensure they meet specified quality standards. QC helps prevent contaminated or substandard products from reaching consumers and maintains compliance with regulatory requirements through proper documentation and testing procedures.

What is the difference between Gmp Quality Control vs Gmp Quality Assurance?

AspectGmp Quality ControlGmp Quality Assurance
Primary FocusTesting and inspecting products to ensure compliance with standardsDeveloping and maintaining quality systems and processes
ResponsibilitiesSampling, testing, and documenting product qualityAuditing, process validation, and quality system oversight
CertificationsGMP training, laboratory skillsGMP knowledge, quality management system training
Work EnvironmentLaboratories, manufacturing sitesQuality departments, compliance offices

Gmp Quality Control focuses on testing products to verify they meet quality standards, while Gmp Quality Assurance involves establishing and maintaining systems to prevent defects. Both roles are essential in ensuring product safety and compliance in the pharmaceutical and biotech industries.

Is GMP Quality Control a good career?

GMP Quality Control is a vital role in the pharmaceutical and biotech industries, focusing on ensuring products meet regulatory standards through testing and documentation. It often requires attention to detail, knowledge of Good Manufacturing Practices, and certifications such as GMP training. The career offers stability, opportunities for advancement, and the chance to work in regulated environments that prioritize quality and safety.

What are popular job titles related to Gmp Quality Control jobs in California?

For Gmp Quality Control jobs in California, the most frequently searched job titles are:

What job categories do people searching Gmp Quality Control jobs in California look for?

The top searched job categories for Gmp Quality Control jobs in California are:

What cities in California are hiring for Gmp Quality Control jobs?

Cities in California with the most Gmp Quality Control job openings:

Gmp Quality Control jobs near you
Infographic showing various Gmp Quality Control job openings in California as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 14% Part Time, 2% Temporary, 3% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution.

Associate Director, Quality Assurance (GMP QC Lab Oversight)

Coherus Oncology

Camarillo, CA • On-site

Full-time

Re-posted 11 days ago

Job description

Title: Associate Director, Quality Assurance (GMP QC Lab Oversight)
Reports to: Head of Quality Assurance Operations
Location: Camarillo, CA (On-site)
Classification: Exempt
Overview:
The Associate Director, Quality Assurance provides strategic and operational QA oversight of GMP Quality Control laboratory activities at the Camarillo site and reports to the Head of QA Operations. This role requires a regular on-site presence to effectively support daily GMP QC laboratory operations.
Key responsibilities include ensuring compliant laboratory operations through oversight of laboratory systems, facilities, and the qualification and validation of instruments and equipment. The role is accountable for review and approval of Certificates of Analysis (CoAs) and other GMP documentation, supporting laboratory investigations and batch disposition decisions, and contributing to Quality Management Review processes. The Associate Director also serves as a key partner to QC in driving inspection readiness, continuous improvement, and sustained GMP compliance.
Responsibilities:
  • Provide QA oversight of GMP QC laboratory operations to ensure compliance with cGMP, FDA, and ICH requirements.
  • Oversee QC laboratory systems, instruments, and equipment throughout their lifecycle, ensuring they remain in a validated and inspection-ready state.
  • Review and approve QC-related GMP documentation, including analytical records, CoAs/CoTs, method qualification and validation reports, stability data, deviations, CAPAs, and change controls.
  • Lead and oversee laboratory investigations (e.g., OOS, OOT, deviations, and data integrity events), ensuring robust root cause analysis, appropriate impact assessment, and timely, compliant resolution.
  • Support batch disposition by ensuring QC data, CoAs, investigations, and associated documentation are complete, accurate, and compliant with internal procedures and regulatory expectations.
  • Partner cross-functionally with QC, Manufacturing, Regulatory, and site leadership to ensure compliant laboratory operations, drive continuous improvement, and maintain sustained inspection readiness.
  • Provide QA support and oversight for method transfer, validation, and technical transfer activities impacting QC laboratory operations.
  • Collaborate with Facilities, IT, and QC to support equipment implementation, qualification, maintenance, and resolution of operational issues impacting GMP laboratory activities.
  • Support and participate in internal audits, external audits, and regulatory inspections; contribute to inspection readiness activities and timely, effective responses.
  • Contribute to Quality Management Review processes (e.g., QMR, PQR/APQR), including analysis of QC performance metrics, identification of quality trends, and execution of continuous improvement actions.
  • Escalate significant quality risks and critical issues to the Head of Quality Assurance and senior leadership, as appropriate.
  • Drive development, enhancement, and continuous improvement of SOPs, QA processes, and QC-related quality systems.

Qualifications:
  • Bachelor's degree in a scientific discipline (or equivalent experience) with a minimum of 8 years of direct experience supporting GMP QC laboratory operations in a regulated pharmaceutical or biotechnology environment, including QA oversight.
  • Demonstrated experience in biologics/protein therapeutics, including manufacturing and testing of drug substance, drug product, and finished goods.
  • Demonstrated experience handling QC-related issues, records, and laboratory operations, including analytical documentation, deviations, and investigations, within a GMP environment; prior hands-on QC laboratory experience strongly preferred.
  • Experience reviewing and approving equipment and instrument qualification and validation documentation (e.g., IQ/OQ/PQ), with working knowledge of lifecycle management principles; experience applying risk-based approaches to computerized systems (GAMP 5) preferred.
  • Strong working knowledge of FDA cGMP regulations and ICH guidelines applicable to QC laboratory operations.
  • Experience leading and/or overseeing laboratory investigations, including OOS, OOT, deviations, CAPAs, change control, and data integrity events within a GMP environment.
  • Solid understanding of CoA/CoT generation and approval, and experience supporting batch disposition decisions in a GMP setting.
  • Demonstrated experience supporting internal audits, external audits, and regulatory inspections, including inspection readiness and response activities.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively influence cross-functional teams.
  • Proven ability to exercise sound judgment, prioritize effectively, and operate successfully in a fast-paced, on-site GMP environment.

Additional requirements
  • On-site presence in Camarillo is required to support daily GMP QC laboratory operations.
  • Up to 20% travel may be required to support audits, external laboratories, or business needs.

The Base Salary Range for this position is $170,000 to $200,000. Coherus considers various factors, including professional background and work experience, when determining base pay. These considerations mean actual compensation will vary.
Coherus provides equal employment opportunities to all employees and applicants for employment and prohibits unlawful discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We also prohibit discrimination based on the perception that anyone has any of these characteristics or is associated with a person who has or is perceived as having any of these characteristics.

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