Quality Assurance Specialist - Pharmaceudicals

Actalent; Hopkins (MN); On-site; USD 34,000 - 41,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Leave

Job summary

Actalent is seeking a Quality Assurance Specialist to ensure product quality and regulatory compliance on the Eden Prairie, MN manufacturing floor. The role involves auditing the facility, evaluating materials and finished products, and driving continuous improvement with rigorous documentation and training.

Required are a biology/chemistry background and 1+ year in GMP manufacturing, with experience in investigations, CAPA, and quality systems.

Qualifications

• Bachelor's degree in Biology, Chemistry, or a related scientific discipline.
• 1+ year in a GMP-regulated manufacturing environment (pharmaceutical, medical device, etc.).
• Experience reviewing batch records, manufacturing documentation, or production records.
• Working knowledge of GMP, GDP, FDA regulations, and quality systems.
• Experience with investigations, deviations, non-conformances, OOS events, and CAPA processes.

Responsibilities

• Review batch records and manufacturing documentation to ensure GMP/GDP compliance.
• Support manufacturing operations through floor presence, audits, inspections, and quality oversight.
• Investigate deviations, non-conformances, and OOS events; perform root cause analysis and support CAPA activities.
• Train and mentor production personnel on quality systems, SOPs, and regulatory requirements.
• Approve production activities and product releases while ensuring specifications are met.
• Maintain and update SOPs, work instructions, controlled forms, and quality documentation.
• Identify recurring quality issues, implement corrective actions, and drive continuous improvement initiatives.
• Partner with production and warehouse teams to promote a strong quality culture and maintain compliance.
• Support lean manufacturing initiatives, including 5S and waste reduction efforts.

Skills

GMP knowledge

Quality systems

Investigations

Education

Bachelor's degree in Biology, Chemistry, or related

Job description

Quality Assurance Specialist

Long-Term Opportunity | Pharmaceuticals | Offers Benefits

The QA Specialist plays a key role in ensuring product quality and regulatory compliance by auditing the facility and production lines, evaluating raw materials, bulk, and finished products, and driving continuous improvement efforts. This position is highly visible on the manufacturing floor and supports a world-class manufacturing control program through careful documentation review, training, and proactive quality oversight.

Key Responsibilities

• Review batch records and manufacturing documentation to ensure GMP/GDP compliance.
• Support manufacturing operations through floor presence, audits, inspections, and quality oversight.
• Investigate deviations, non-conformances, and OOS events; perform root cause analysis and support CAPA activities.
• Train and mentor production personnel on quality systems, SOPs, and regulatory requirements.
• Approve production activities and product releases while ensuring specifications are met.
• Maintain and update SOPs, work instructions, controlled forms, and quality documentation.
• Identify recurring quality issues, implement corrective actions, and drive continuous improvement initiatives.
• Partner with production and warehouse teams to promote a strong quality culture and maintain compliance.
• Support lean manufacturing initiatives, including 5S and waste reduction efforts.

Required Qualifications

• Bachelor's degree in Biology, Chemistry, or a related scientific discipline.
• 1+ year of experience in a GMP-regulated manufacturing environment (pharmaceutical, medical device, food, cosmetic, etc.).
• Experience reviewing batch records, manufacturing documentation, or production records.
• Working knowledge of GMP, GDP, FDA regulations, and quality systems.
• Experience with investigations, deviations, non-conformances, OOS events, and CAPA processes.

Job Type & Location

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

Workplace Type This is a fully onsite position in Eden Prairie,MN.

Pay And Benefits

The pay range for this position is $25.00 - $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)

Application Deadline This position is anticipated to close on Oct 7, 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 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 [e-mail] 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.