QC Manager

Job Description

Join our dynamic team as a QC Manager to support external contract organization activities, ensuring all GMP QC testing needs are met efficiently. Provide crucial internal support to CMC Operations to aid in the development, manufacture, and release of materials. This includes method transfer, qualification, validation, and managing product shelf life. Collaborate closely with PDAS, Manufacturing, CROs for technical transfer of testing methods and assays, and troubleshoot as necessary. Ensure strict compliance with regulatory standards including FDA, EMA, and other agencies. Develop and validate analytical methods for QC testing, implement quality systems for data integrity, manage release/stability data, and generate reports. Work within multiple departments to address QC document reviews and manage documentation through eQMS systems like ZenQMS. Track stability time points, create and update tables for stability data, and manage change controls, deviations, and CAPA within eQMS.

Hard Skills

• mRNA

• LNP

• Microbiology

• Stability Testing

• Biologics

• CMC

Soft Skills

• Collaboration

• Troubleshooting

• Regulatory Compliance

• Quality Assurance

• Documentation Management

Job Type

This is a contract position with a duration of 9 Month(s).

Work Site

This is a fully on-site position in Lexington, Massachusetts.

Additional Skills & Qualifications

• Bachelor's Degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related Life Science field with 5-8 yrs experience within the biotech/pharma industries

• 3+ years of Analytical / Quality Control experience in a GMP environment

• Good understanding of cGMPs, ICH stability, and Regulatory Drug requirements

Work Environment

The position requires initial onsite presence for 30-40 hours weekly to become acquainted with the project, followed by a potential reduction to 20 hours. A hybrid work schedule is supported, offering flexibility in working hours.

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.