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Actalent Quality Assurance Specialist - Team Lead in REDMOND, Washington

We are a mission-driven bio-pharmaceutical company addressing global health inequalities by empowering people to live healthy lives. We do this by developing novel vaccines targeting infectious diseases for which there are no current preventive interventions or by optimizing currently marketed vaccines to provide a broader spectrum of protection, making them cheaper and more stable than before. We aspire to provide breakthrough public health interventions for all populations, globally. We are led by pioneers in vaccine discovery, seasoned experts in manufacturing and vaccine development, and proven commercialization veterans.

Essential Functions:

  • Manage quality assurance team to develop, execute, and complete assignments

  • Organize team roles and evaluate performance

  • Document operational tasks and report to management

  • Perform employee reviews and assessments

  • Assist with new employee onboarding and training program

  • Register’s equipment and instrumentation onto the master asset list, as well as the calibration and preventative maintenance program.

  • Maintains and review validation protocols and reports.

  • Prepares selected training programs for specific quality systems subjects, such as GMP, data integrity, and good documentation practices.

  • Supports Safety Training.

  • Verifies product changeovers (PCOs)/line clearances used to ensure proper cleaning, disinfections, and release of work areas and equipment for subsequent use.

  • Reviews and approves applicable logbooks and test records to ensure complete, timely, and accurate recording of data.

  • Applies good documentation practices in all aspects of executing job responsibilities, which include the routine and random review of GMP documentation.

  • Maintains and archives all Material Safety Data Sheets (MSDS) for all chemicals used, as well as for finished products.

  • Supports and reviews data integrity program as needed.

  • Supports and facilitates material controls in order to assure consistent and appropriate assignment of material quality status, retest date/ expiration date, first-in, first-out (FIFO), segregation of quarantine and rejected materials, and associated documentation and inventory tracking of GMP materials.

  • Supports the room checklist program to assure routine facility conditions are acceptable for use, and that housekeeping and/or maintenance needs are elevated immediately.

  • Oversees pest control program, materials used, applications, and associated contractors.

  • Ensure proper document archiving and record retention programs are put into place and enforced.

  • Supports associated investigations and impact assessment when excursions occur.

  • At management’s request, conducts internal compliance audits, which may be scheduled in accordance with procedure, or for cause.

Educational Requirements:

Bachelor’s Degree with at least 3 years of experience.

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

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.