Quality Assurance Specialist

Quality Scientist

Job Description

The Quality Assurance Specialist will support critical documentation and technology transfer projects by transferring, reformatting, and maintaining Standard Operating Procedures (SOPs) and related documentation. The role focuses on immunoassay, formulation, and cell culture transfer projects, ensuring that legacy documents are accurately migrated into current SOP templates in a regulated GMP environment. This position offers the opportunity to contribute to new product introduction, site transfer initiatives, and continuous improvement activities within operations.

Responsibilities

• Transfer and reformat existing Standard Operating Procedures (SOPs) and related documents into current SOP templates with a high degree of accuracy and consistency.
• Review legacy documentation for immunoassay, formulation, and cell culture transfer projects and ensure all relevant information is captured and updated in new formats.
• Perform data entry and documentation updates in accordance with GMP requirements and internal quality standards.
• Support documentation activities associated with technology transfer projects involving cell culture, particles, and formulation work.
• Apply working knowledge of SOP writing to create, revise, and maintain clear and compliant procedures.
• Utilize production formulation experience, including weighing materials and chemicals, operating equipment such as spectrophotometers, and measuring pH, to ensure technical accuracy of documents.
• Contribute to quality assurance processes by supporting the creation and maintenance of CAPAs (Corrective and Preventive Actions) and supplier notifications.
• Work with change order and inventory management systems to track and control document and process changes.
• Collaborate with a cross-functional team focused on new product introduction, site transfer projects, CAPAs, end-of-life products, maintenance requests, and supplier notifications.
• Maintain meticulous attention to detail and organization while working at a desk in a documentation-focused role.
• Demonstrate an interest in continuing with the organization beyond the initial documentation project, contributing to ongoing quality and operations initiatives.

Essential Skills

• Bachelor’s degree in a life science discipline such as chemistry, biology, biochemistry, or microbiology.
• At least 6 months of experience working in a GMP (Good Manufacturing Practice) environment.
• At least 6 months of experience with writing or contributing to SOPs.
• At least 6 months of production formulation experience, including weighing materials and chemicals, utilizing a spectrophotometer, and measuring pH.
• At least 3 months of experience working around immunoassay manufacturing.
• Demonstrated experience in quality assurance or closely related laboratory quality functions.
• Strong data entry skills with high accuracy and attention to detail.
• Ability to follow and interpret laboratory and formulation procedures.
• Solid understanding of documentation practices in a regulated environment.

Additional Skills & Qualifications

• Experience with writing or supporting CAPAs (Corrective and Preventive Actions).
• Experience preparing or managing supplier notifications.
• Familiarity with change order systems and inventory management systems.
• Interest in long-term career growth and continuing internally after the initial project.
• Strong organizational and time-management skills to handle multiple documentation tasks and projects.
• Ability to work effectively with a team focused on new product introduction and site transfer activities.
• Comfort working in a highly documentation-driven, quality-focused role.

Work Environment

This is a full-time, Monday–Friday, first-shift position, with flexible start times between 6:00 a.m. and 9:00 a.m., and an 8.5-hour workday. The role is 100% desk-based and centers on documentation and quality assurance activities rather than hands-on bench work. You will join a team that recently underwent a reorganization and is focused on new product introduction in operations, site transfer projects, CAPAs, end-of-life products, maintenance requests, and supplier notifications. Most team members have biochemistry or chemistry backgrounds, with additional expertise in product labeling and inventory management. The environment emphasizes collaboration, accuracy, and adherence to GMP and quality standards while supporting technology transfer projects involving cell culture, particles, and formulation work.

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

The pay range for this position is $28.00 - $30.00/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)

This is a fully onsite position in Chaska,MN.

This position is anticipated to close on Jun 3, 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Salary : $28 - $30