QA Associate II

Great opportunity to join a growing cell and gene therapy company as a QA Associate II!

Job Description:

This position is a short-term contract (4 months) supporting the first shift.

Read, understand, and follow all cGMP and cGTP documentation for Quality System Functions (SOPs, WIs, etc.).

Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical, and commercial manufacturing.

Perform raw material inspections and raw material release according to SOPs and in compliance with all regulatory standards.

Issue batch records and review media (intermediate) batch records.

Manage and maintain all cGMP and cGTP documentation, including but not limited to logbooks and training binders.

Perform accessioning of incoming apheresis.

Conduct line clearance prior to the commencement of manufacturing operations.

Ensure quality is built into all aspects of work by maintaining compliance with all quality requirements.

Ensure compliance with all FDA and Worldwide Quality & Compliance regulations (as applicable to the job function).

Attend all required Quality & Compliance training at the specified intervals.

Skills & Qualifications:

BS degree in a scientifically related field.

Some experience in a biologics or biotechnology company preferred.

Working knowledge and technical understanding of the aseptic manufacture of biologics preferred.

Working knowledge of cGMP and cGTP regulations.

Work Environment:

Must have the ability to work in a team-oriented environment and with clients.

Must be able to work during weekends, holidays, and as required by the company.

May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids.

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.

Must have the ability to work with specialized equipment.

Must be able to handle the standard/moderate noise of the manufacturing facility.

GXP training, SOP & WI training, Safety Training, and Gowning qualification required.

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.