Quality Assurance Specialist

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

Benefits offered by this job

Medical, dental & vision

401(k)

Time Off / PTO

Career development

Job summary

Actalent is hiring a Quality Assurance Specialist in Eden Prairie, MN for a long-term contract to hire role focused on auditing facilities, reviewing batch records, and ensuring regulatory compliance. The role emphasizes continuous improvement, training, and documentation control across GDP and USP standards.

Onsite position with comprehensive benefits and a competitive hourly rate. The ideal candidate has 1–2 years of GMP experience, a Bachelor's in Chemistry/Biology or related field, and

Qualifications

• Experience in GMP manufacturing environments such as pharmaceuticals, medical devices, cosmetics, or food manufacturing.
• Experience reviewing batch records and/or compounding records.
• Bachelor's degree in Chemistry, Biology, or related field is preferred.
• 1-2 years of relevant experience.
• Knowledge of GMP, CAPA, FDA regulations, and auditing.

Responsibilities

• Review Production Batch Records to uphold a world-class manufacturing control program with a focus on training and accuracy.
• Ensure documentation records comply with GDP requirements and current SOPs, Work Instructions, and test procedures.
• Train personnel to improve compliance with regulatory and quality requirements and provide technical and process direction.
• Utilize interpersonal skills to foster a culture of quality and heighten quality awareness.
• Document and investigate deviations and out-of-specification situations.
• Ensure SOPs, Work Instructions, controlled forms, and test methods are updated proactively to support improvements and compliance.
• Ensure product quality specifications and customer standards are met and maintained to the customer's satisfaction.
• Complete approvals to run as needed and ensure quality events are properly documented and escalated.
• Ensure products meet specifications before release and that current reference and product standards are maintained.
• Utilize data to focus improvement efforts and ensure customer and regulatory requirements are met.
• Accurately record data and pertinent information (cGMP) and resolve ongoing quality issues permanently.
• Document out-of-specification situations, determine root cause, and propose solutions to prevent recurrence.
• Maintain compliance with current regulatory expectations and practices (e.g., USP).
• Implement and maintain standards and processes that eliminate waste within the department.
• Apply and utilize 'lean tools' to implement improvements and institutionalize 5-S in all aspects of the department.

Skills

GMP knowledge

Auditing

Documentation review

Training personnel

Lean tools

Education

Bachelor's degree in Chemistry, Biology, or related field

Job description

Quality Assurance Specialist

Long-Term Opportunity | Pharmaceuticals | Offers Benefits

Job Description

As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of products by auditing facilities and production lines, evaluating raw materials, and engaging in continuous improvement efforts. Your work will support the success of our customers by maintaining high standards of quality.

Responsibilities

• Review Production Batch Records to uphold a world-class manufacturing control program with a focus on training and accuracy.
• Ensure documentation records comply with GDP requirements and current SOPs, Work Instructions, and test procedures.
• Train personnel to improve compliance with regulatory and quality requirements and provide technical and process direction.
• Utilize interpersonal skills to foster a culture of quality and heighten quality awareness.
• Document and investigate deviations and out-of-specification situations.
• Ensure SOPs, Work Instructions, controlled forms, and test methods are updated proactively to support improvements and compliance.
• Ensure product quality specifications and customer standards are met and maintained to the customer's satisfaction.
• Complete approvals to run as needed and ensure quality events are properly documented and escalated.
• Ensure products meet specifications before release and that current reference and product standards are maintained.
• Utilize data to focus improvement efforts and ensure customer and regulatory requirements are met.
• Accurately record data and pertinent information (cGMP) and resolve ongoing quality issues permanently.
• Document out-of-specification situations, determine root cause, and propose solutions to prevent recurrence.
• Maintain compliance with current regulatory expectations and practices (e.g., USP).
• Implement and maintain standards and processes that eliminate waste within the department.
• Apply and utilize 'lean tools' to implement improvements and institutionalize 5-S in all aspects of the department.

Additional Skills & Qualifications

• Experience in GMP manufacturing environments such as pharmaceuticals, medical devices, cosmetics, or food manufacturing.
• Experience reviewing batch records and/or compounding records.
• Bachelor's degree in Chemistry, Biology, or related field is preferred.
• 1-2 years of relevant experience.
• Knowledge of GMP, CAPA, FDA regulations, and auditing.

Job Type & Location

This is a Contract to Hire position based out of 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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Oct 5, 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.