QA Specialist - with Growth Opportunities

Randstad in partnership with one of the largest pharmaceutical companies in the worldis seeking a Specialist/Senior Specialist to support Quality On The Floor (OTF) oversight of manufacturing activities and Facilities at Moderna Inc. This position will be based in our cGMP Manufacturing site in Burlington, MA and will directly support the growing Personalized Medicine Program.

Responsibilities

• Provide quality on-the-floor support of manufacturing, reviewing documentation, and providing real-time support of manufacturing issues change overs etc.
• Support quality decisions that may impact operations, ensuring appropriate escalation.
• Identify risks and communicate gaps for quality and GMP process/systems.
• Reviews and approves facility alarms, facility work order requests, and return-to-service documentation.
• Support, reviews and approves Deviations and CAPAs
• Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations.
• Collaborate with Manufacturing to resolve equipment and process issues
• Support internal audits.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• GMP
• GxP regulations

Qualifications
• Years of experience: 4 years
• Experience level: Experienced

Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad.




Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

Applications accepted on ongoing basis until filled.