Description:

Quality Assurance Specialist – Quality Systems, supports all quality system elements to assure compliance with FDA cGMP and other quality standards, with primary responsibilities in Regulatory submission review, Annual Product Review, Supplier Quality and external auditing.

Provide quality oversight for regulatory submissions/updates.

Final review of Annual Product Review (APR) before submission.

Oversight of external and supplier quality functions including qualifying new suppliers, auditing new and existing suppliers, and maintaining compliance for quality agreements.

Support of the Change Control Process specifically for supplier changes.

Support Supplier Qualification Program.

Support updates to the Approved Vendor/Supplier list..

Perform Internal and External Audits per annual audit schedules

May also participate in other Quality Systems responsibilities including:

Tracking and Trending of Quality Data, Training, supporting site Data Integrity requirements, etc.

Support site Data Integrity requirements.

Provide metrics for Quality Review Board, as requested.

Provide support during HACCP, FDA and other inspections.

Additional Skills & Qualifications:

Bachelor’s degree strongly preferred; Degree in Biology, Chemistry or related field of study preferred

3 – 5 years of experience in a FDA regulated pharmaceutical facility preferred

3 – 5 years of experience in Quality Assurance / Quality Systems

Must have exposure and experience with one of the primary areas of responsibility (Regulatory review, APR review, External/Supplier Quality)

Experience Level:

Intermediate Level

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 for other accommodation options.