QC Scientist - Bioassay

Job Title: QC Scientist - Bioassay

Job Description

This role involves conducting QC analysis of raw materials, in-process, drug substance, and drug product samples to support GMP manufacturing operations at our facilities in Seattle and Redmond, WA. Your efforts will contribute to the manufacturing activities of biotherapeutic products under GMP regulations.

Responsibilities

• Perform routine and non-routine QC testing using techniques such as cell-based assays, ELISA, and qPCR.
• Ensure timely and accurate completion of GMP documentation.
• Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of analytical methods.
• Conduct laboratory investigations, manage deviations, out-of-specification results, change controls, and CAPAs.
• Support equipment qualification processes, including IQ, OQ, and PQ.
• Create, maintain, and revise SOPs, methods, and associated documents.
• Support all operations of the QC labs, including ordering supplies and maintaining laboratory equipment and spaces.
• Contribute to client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical-related matters.
• Participate in daily and weekly operational meetings.

Essential Skills

• Bachelor's degree in Biochemistry, Molecular/Cellular Biology, Chemistry, or a related field.
• 3-5 years of Quality Control experience in the GMP biopharmaceutical or biotechnology industry.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.
• Hands-on experience in executing potency and impurity methods such as cell-based assays, immunoassays, and qPCR.

Additional Skills & Qualifications

• Laboratory experience with mammalian cell culture and cell banking.
• Ability to adapt and work in a fast-paced environment, managing multiple projects and priorities.
• Excellent oral, written, and interpersonal communication skills.
• Proficiency in Microsoft Office Suite, including Excel, Word, and PowerPoint.

Work Environment

Work will be conducted at GMP manufacturing facilities in Seattle and Redmond, WA. The environment is fast-paced and requires adaptability, with duties involving regular use of laboratory equipment and technology. Collaborative work with various teams is essential, as is maintaining a clean and organized lab space.

Pay and Benefits

The pay range for this position is $42.00 - $52.00/hr.

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 Redmond,WA.

Application Deadline

This position is anticipated to close on Jul 2, 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.

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 due to a disability, please email ... for other accommodation options.