Quality Assurance Specialist

ACTalent

Minnetonka (MN)

On-site

USD 36,000 - 41,000

Full time

11 days ago

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Benefits offered by this job

Medical, dental & vision
401(k) Retirement Plan
Life Insurance
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
PTO / Vacation

Job summary

Actalent is seeking a Quality Assurance Specialist for a fully onsite, day-shift contract-to-hire role in Minnetonka, MN. You will review batch records, COAs, and documentation to ensure compliance with cGMP and internal quality standards before product release, contributing to product safety and regulatory readiness.

You will manage deviations, CAPAs, change controls, and investigations, support continuous improvement with Lean tools, and write quality documentation.

Qualifications

  • 3+ years of quality experience in a cGMP manufacturing environment.
  • Strong knowledge of cGMP, GDP, and quality documentation requirements.
  • Hands-on experience with deviations, CAPAs, investigations, change controls, and batch record review.

Responsibilities

  • Review batch records and supporting documentation for accuracy and compliance prior to final approval and product release.
  • Verify calculations, specifications, and manufacturing data to meet internal quality standards and customer requirements.
  • Prepare and review Certificates of Analysis (COAs) and other required quality and manufacturing documentation.
  • Manage quality system activities including deviations, CAPAs, change controls, quality alerts, and annual product reviews.
  • Support investigations related to deviations and quality events, ensuring proper documentation and justification.
  • Support continuous improvement using Lean Manufacturing principles, 5S, and other Lean tools.
  • Assist with writing deviations, investigations, and other quality documentation to support compliance.

Skills

Quality Systems Experience
cGMP Knowledge
Quality Documentation
Deviations & CAPAs Handling

Education

Bachelor's degree in a scientific discipline or related field

Job description

Quality Assurance Specialist
Fully Onsite | Long-Term Opportunity | Day Shift Hours
Job Description

The QA Specialist ensures that all manufacturing documentation and quality system activities comply with cGMP and internal quality standards before product release. In this role, you review batch records and supporting documentation, prepare and verify Certificates of Analysis, manage key quality system processes, and support investigations and continuous improvement initiatives. You play a critical role in making sure products are safe, compliant, and ready for the consumer market.

Responsibilities
  • Review batch records and all supporting documentation for accuracy, completeness, and compliance with cGMP and Good Documentation Practices prior to final approval and product release.

  • Verify calculations, specifications, and manufacturing data to ensure documentation meets internal quality standards and customer requirements.

  • Prepare and review Certificates of Analysis (COAs) and other required quality and manufacturing documentation.

  • Manage quality system activities including deviations, corrective and preventive actions (CAPAs), change controls and change orders, quality alerts, customer complaints, and Annual Product Reviews in accordance with standard operating procedures and customer or partner agreements.

  • Support and prepare investigations related to deviations and other quality events, ensuring issues are properly documented, thoroughly investigated, and justified.

  • Support continuous improvement initiatives by applying Lean Manufacturing principles, 5S, and other Lean tools to improve processes and eliminate waste.

  • Assist with writing deviations, investigations, and other quality documentation to support overall compliance with the companys quality systems.

Additional Skills & Qualifications
  • Bachelors degree in a scientific discipline or related field, or equivalent education and experience.

  • 3+ years of quality experience in a cGMP manufacturing environment.

  • Strong knowledge of cGMP, GDP, and quality documentation requirements.

  • Hands-on experience with quality systems, including deviations, CAPAs, investigations, change controls, and batch record review.

Work Environment

This is a full-time QA Specialist position working a consistent daytime schedule with a typical start time between 7:00 AM and 9:00 AM. The role is fully onsite at a manufacturing facility and is primarily office-based, with your own cubicle and autonomy to manage your day and workload.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $26.00 - $30.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 17, 2026.

Workplace Type

This is a fully onsite position in Minnetonka,MN.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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.

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