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Job Title: QC AssociateJob Description

The incumbent is responsible for establishing the QC release testing of immunotherapy products with a focus on cell-based test methods. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs). This role will serve as a key member of the QC team and will partner closely with the Analytical Development (AD) and Manufacturing teams for training, transferring test methods, and releasing drug products.

Responsibilities

• Work cross-functionally with AD in the transfer and qualification of the cell-based test methods

• Perform routine in-process and release testing of cell therapy products

• Maintain human cell lines

• Create test method transfer and validation protocols

• Author test methods and supporting Standard Operating Procedures (SOPs) for the QC Laboratories

• Maintain critical reagents inventory and qualification for QC labs

• Perform routine preventative maintenance on QC equipment

Essential Skills

• 3-5+ years of GMP industry experience in a lab setting

• 3-5+ years of lab testing within GMP compliance

• 3-5+ years of real-time PCR experience

• Experience with cell-based assays

• Knowledge of Flow Cytometry and Cell Biology

Additional Skills & Qualifications

• BSc degree with 7 years’ experience in a relevant field (e.g., Immunology, Cell Biology)

• MSc degree with 4 years’ experience in a relevant field (e.g., Immunology, Cell Biology)

• A minimum of 5 years of cell-based testing within a regulated cGMP environment

• Experience in lab build-up

• Quality systems experience in managing deviations, CAPAs

• Execution of method validation in a commercial facility

• Good Documentation Practices (GDP) and ALCOA required

• Good organizational and time management skills

• Good oral and written communication for effective interpersonal collaboration

• Ability to work in a team environment and perform job responsibilities with reasonable supervision

• Exceptional attention to detail

• Identify opportunities for operational excellence, application of Lean principles and continuous improvement

• Must be proactive, action-oriented and adaptable to change

• Experience with real-time PCR, FCS Express (Flow), and/or cell-based assays and passaging is a plus

• Experience in a technical role within a GMP biopharmaceutical manufacturing operation

Work Environment

Working onsite in a lab GMP environment with a team size of 7. The shifts are from Wednesday to Saturday, 4 hours per day.

Pay and Benefits

The pay range for this position is $45.00 - $52.00

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Bothell,WA.

Application Deadline

This position will be accepting applications until Jan 31, 2025.

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.