Job Description
Job Description
Quality Assurance Scientist
Job Description
This role focuses on manufacturing quality assurance, encompassing approvals and review of design changes, material changes, validations, nonconformances, and other quality documentation. It also provides 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.
- Lead efforts to 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 and DFMEAs.
- 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
- Bachelor's degree in science.
- 3+ years of experience in a GMP/GDP lab setting.
- Strong technical writing skills.
- 2+ years of experience with design change processes in a regulated environment.
- 2+ years of experience reviewing design change and validation documentation (equipment/process for laboratory equipment including bioreactors, cell counters, biosafety cabinets, incubators).
- Knowledge of FDA regulations and a focus on risk assessment.
Additional Skills & Qualifications
- 1+ years of cell culture experience.
- Experience with bioreactors.
- Experience in mammalian cell culture.
- Medical device, pharmaceutical manufacturing, or biologic manufacturing.
Work Environment
This position is on the 1st shift, Monday to Friday, with start times between 8-9am. The role involves working in a small group within a larger organization that is in the early phase of a project launch. The person in this role will help alleviate current scientists from performing more QA functions, allowing them to stay in the lab. Work will be received from the document control coordinator, with a focus on assessing downstream impacts.
Job Type & Location
This is a Contract to Hire position based out of Chaska, MN.
Pay and Benefits
The pay range for this position is $42.00 - $48.14/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 Chaska,MN.
Application Deadline
This position is anticipated to close on Mar 31, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.