Quality Control Scientist - Analytical Chemistry

Job Title: Quality Control Scientist - Analytical

Job Description

This role involves conducting QC analysis of raw materials, in-process samples, drug substances, and drug product samples to support GMP manufacturing operations at facilities located in Seattle and Redmond, WA. The position plays a critical role in ensuring the quality of biotherapeutic products.

Responsibilities

• Perform routine and 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, handle deviations, manage out-of-specification (OOS) results, and implement change controls and corrective and preventive actions (CAPAs).
• Support equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Create, maintain, and revise Standard Operating Procedures (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 and 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 Chemistry, Biochemistry, or related field.
• 3-5 years of Quality Control experience in the GMP biopharmaceutical or biotechnology industry.
• Laboratory experience with HPLC or UPLC chromatography systems and capillary electrophoresis techniques.
• Familiarity with chromatography data systems.
• Knowledge of GMP regulations and experience with regulatory compliance inspections.

Additional Skills & Qualifications

• Ability to adapt and work in a fast-paced environment.
• Capability to manage multiple projects and priorities simultaneously.
• Excellent oral, written, and interpersonal communication skills.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Work Environment

The work environment includes operating in GMP facilities located in Seattle and Redmond, WA. The role requires interaction with sophisticated laboratory equipment and technologies such as HPLC, UPLC, and capillary electrophoresis systems. The position involves working in a dynamic and fast-paced environment, requiring flexibility and the ability to manage multiple tasks. The dress code is business casual, suitable for laboratory settings.

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 Seattle,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.