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Quality Assurance Manager

Quality Assurance Manager

ActalentIrvine, CA, US
16 hours ago
Job type
  • Permanent
Job description

Quality Assurance Manager

We are seeking a Quality Assurance Manager to lead the development, maintenance, and improvement of technical documentation, including SOPs, quality manuals, policies, procedures, and regulatory submissions. The successful candidate will ensure all documentation is accurate, complete, and compliant with GMP, FDA, NSF, and other relevant regulatory requirements.

Responsibilities

  • Oversee documentation for vendors and manufacturing sites, such as batch records, quality reports, and regulatory filings.
  • Collaborate with R&D, quality, and manufacturing teams to document test methods, laboratory compliance procedures, and validation protocols.
  • Maintain centralized documentation systems with proper version control, traceability, and accessibility.
  • Support internal and external audits by preparing and organizing required documentation.
  • Conduct gap analyses of documentation and implement corrective actions to address deficiencies.
  • Mentor and train team members on documentation practices and regulatory writing standards.
  • Manage documentation fulfillment for customers and regulatory bodies, ensuring timely and accurate delivery.
  • Support quality investigations, CAPA programs, and customer complaint responses through accurate documentation.

Essential Skills

Bachelor's degree required; Master's degree or equivalent preferred in Chemistry, Biology, Food Science, or related scientific discipline.

Minimum 10 years of relevant experience within food / bev, nutraceutical, dietary supplement, or pharma, with at least 5 years in managerial roles overseeing GMP documentation and technical writing.

Experience with CFR part 117 and 111.

Demonstrated experience in creating, reviewing, and maintaining technical documentation for manufacturing, laboratory, and quality operations.

Proven track record in implementing and improving quality documentation systems, SOPs, and compliance manuals.

Strong ability to interpret regulatory language and translate it into clear, actionable documentation.

Excellent organizational, leadership, and mentoring skills.

High ethical standards, adaptability, initiative, and professionalism in a fast-paced, regulated environment.

Additional Skills & Qualifications

Experience in supplier qualification audits.

Experience having hosted, led, or participated in audits within the industry.

Certifications like PCQI and SQF, FDA, cGMP, Food Safety are nice to have.

Experience within nutraceutical, food / bev, dietary supplement, or pharma is beneficial.

Work Environment

The Quality Assurance Manager will oversee the Quality Department, which is split into two different teams : Quality Assurance and Quality Control. This role is within a fast-moving industry and offers a flexible environment. The position is onsite, Monday to Friday, from 8 am to 5 pm.

Job Type & Location

This is a Permanent position based out of Irvine, CA.

Pay and Benefits

The pay range for this position is $90000.00 - $120000.00 / yr. Standard Benefits : 401K match up to 4%, Health, Dental, Vision, and various optional insurance coverage plans and annual bonus incentive based on organizational and individual performances.

Application Deadline

This position is anticipated to close on Dec 5, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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Quality Assurance Manager • Irvine, CA, US

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