Quality Assurance Compliance Specialist

Great opportunity to get your foot in the door with one of the top Biotech Companies in the Billerica, MA area!

Must have experience with Product Quality Complaints and Annual Product Quality Reviews

If interested, pleas reach out directly to Lindsee Allienello at lallienello @ actalentservices.com

Top Skills' Details:

• Quality Assurance

• Product Compliance

• APQR (Annual Product Quality Reviews)

• Root Cause Analysis

• Quality Management System (Trackwise)

Description:

• Help with documentation, root cause analysis, and QA closure of Stage II OOS investigations and OOT investigations

• technical investigations relating to Product Quality Complaints

• Run quality investigations and risk assessments

• Help run Annual Product Quality Reviews

• Manage QMS (Trackwise)

• Write and review SOPs and test methods

Additional Skills & Qualifications:

• BS in chemistry or related scientific field

• 6-8 years experience in pharmaceutical manufacturing

• Understand GMP/GLP

• Understand QMS and Trackwise

• Exposure to SAP, EDMS, LMS, Master Control

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.