Job Description

Job Description

Job Description

Description

This role provides the QC analysis of raw materials, in-process, drug substance and drug product samples in support of our GMP manufacturing operations at the Seattle and Redmond, WA GMP facilities. These efforts support GMP manufacturing activities for biotherapeutic products.

Responsibilities:

• Perform routine/non-routine QC testing using chromatographic and physiochemical methods.
• 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, deviations, OOS, change controls and CAPAs.
• Support equipment qualification (IQ, OQ, PQ).
• Create, maintain, and revise SOPs, methods and associated documents.
• Support all operations of the QC labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
• Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters.
• Participate in daily and weekly operation meetings.

Additional Skills & Qualifications

• BS in Chemistry, Biochemistry, or related field and with 3-5 years of Quality Control experience in GMP biopharmaceutical or biotechnology industry.
• Laboratory Experience with HPLC / UPLC chromatography systems and capillary electrophoresis (CE) techniques.
• Familiarity with capillary electrophoresis or chromatography data systems.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.
• Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time.
• Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint).

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 Oct 31, 2025.

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 actalentaccommodation@actalentservices.com for other accommodation options.

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