Senior QA Scientist (Cell Manufacturing)

Senior Quality Assurance Scientist

Job Description

This role focuses on manufacturing quality assurance, including approvals and review of design changes, material changes, validations, nonconformances, and other quality documentation—plus direct, project-based support for operational workcells. This is a high-impact role for someone who can independently guide teams through compliance requirements while supporting smart, practical execution in Operations.

Responsibilities

• Provide strategic Manufacturing QA support for regulated manufacturing (FDA QSR).
• Review and approve quality documentation including design changes, deviations, and nonconformances for laboratory equipment and processes.
• Approve equipment and process validations and associated reports.
• Act as an independent quality leader, partnering with cross-functional teams to ensure compliance and prevent nonconformances.
• Improve processes and strengthen quality systems.
• Lead and support advanced nonconforming product management and systemic corrective actions.
• Support risk-based documentation and analysis, including risk assessments, DFMEAs, and related risk documentation.
• Collaborate with R&D, Technical Operations, and Manufacturing to reduce waste and improve customer outcomes.
• Flex across upstream/downstream groups as needed, with a strong focus on compliance and risk.

Essential Skills

• Document control
• Quality assurance
• Validation
• Cell culture
• Design change
• Equipment validation
• Material changes
• Biological manufacturing
• PFMEA
• DFMEA
• Bioreactor design
• Biosafety cabinet

Additional Skills & Qualifications

• Bachelor's degree in science
• 3 years of experience in a GMP/GDP lab setting
• Strong technical writing skills
• Experience with design change processes in a regulated environment
• 2 years of experience reviewing design change and validation documentation for laboratory equipment
• 1 years of cell culture experience
• Strong knowledge of FDA regulations
• Bioreactor experience
• Mammalian cell culture experience

Work Environment

The role operates on a 1st shift, Monday-Friday, with start times between 8-9am. The work environment involves a small group within a larger organization in the early phase of a project launch. The person in this role will help alleviate current scientists performing more QA functions, allowing them to remain in the lab. The individual will receive work from the document control coordinator and assess downstream impacts.

This is a Contract to Hire position based out of Chaska, MN.

The pay range for this position is $30.00 - $33.21/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)

This is a fully onsite position in Chaska,MN.

This position is anticipated to close on Mar 9, 2026.

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $33