Job Title: Quality Assurance SpecialistJob Description

As a Quality Assurance Specialist, you will be responsible for ensuring compliance with all cGMP and cGTP documentation and regulations. You will perform raw material inspections, issue and review batch records, and maintain all quality documentation. Your role is critical in maintaining compliance with FDA and worldwide quality regulations, helping to ensure the safety and efficacy of our products.

Responsibilities

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.

Issue and maintain all cGMP and cGTP documentation, including logbooks and training binders.

Perform accessioning of incoming apheresis.

Perform line clearance prior to the start of manufacturing operations.

Build quality into all aspects of your work by maintaining compliance with all quality requirements.

Ensure compliance with all FDA and worldwide quality and compliance regulations as applicable to the job function.

Attend all required quality and compliance training at specified intervals.

Essential Skills

Quality assurance experience.

Knowledge of batch record review and aseptic techniques.

Ability to perform quality assurance activities under direct supervision.

Experience with document management, review of QC data, material releases, and final product releases.

Understanding of material flow and line clearance.

Additional Skills Qualifications

BS degree in a scientifically related field.

Experience in a biologics or biotechnology company preferred.

Technical understanding of the aseptic manufacture of biologics preferred.

Working knowledge of cGMP and cGTP regulations.

Work Environment

You will work in a team-oriented environment and with clients. This role requires flexibility to work during weekends, holidays, and as needed by the company. You may be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids. Proper personal protective equipment (PPE) must be utilized when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen. The role involves working with specialized equipment and handling the standard/moderate noise of the manufacturing facility. You will receive GXP training, SOP WI training, safety training, and gowning qualification.

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. DEI 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 [email protected] (%[email protected]) for other accommodation options.