Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Job Description

• Receives product quality complaints for products.

• Documents in Quality System for investigation of product quality complaints and triages safety events to the appropriate department.

• Performs or provides support for product quality complaint investigations.

• Performs a variety of activities to ensure compliance with applicable regulatory requirements.

• Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).

• Performs data analysis in support of product quality complaint investigations and quarterly trend analysis.

• Assists lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.

• Manages product complaint samples from receipt through destruction.

• Normally receives general instruction on routine work, detailed instructions on new assignments.

Hard Skills

Writing deviations on pharma/biotech product complaints (not reviewing or approving)

Writing all elements of product complaint deviations

Soft Skills

Working with cross-functional teams/CMOs (mostly via email, minimal meetings)

Job Type

This is a contract position with a duration of 1 Year(s).

Work Site

This is a hybrid position requiring some days on-site in Foster City, California and some days remote.

Work Environment

Hybrid onsite Tues, Wed, Thurs; WFH Mon & Fri.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.