Quality Assurance Manager

Actalent•Irvine, CA

30d•$90,000 - $120,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.