QA Specialist II

Actalent; Hopkins (MN); On-site; USD 60,000 - 80,000; Full time

Job summary

Actalent is seeking a QA Analyst in a GMP manufacturing environment to ensure product quality and compliance through auditing and process improvements. The role involves training staff, maintaining quality standards, and documenting deviations. Ideal candidates will have a degree in Chemistry or Biology and experience in quality assurance within regulated industries.

Benefits

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Short and long-term disability

Employee Assistance Program

Paid Time Off

Qualifications

• 1-2+ years of experience in quality assurance from pharmaceutical or medical device industries.
• Experience reviewing batch records.
• Knowledge of GMP compliance.

Responsibilities

• Review Production Batch Records for quality compliance.
• Train personnel on regulatory and quality standards.
• Document and investigate deviations in product quality.

Skills

Attention to Detail

Quality Awareness

Training

Interpersonal Skills

Education

Bachelor's degree in Chemistry or Biology

High School Diploma with GMP experience

Job description

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Will work in a GMP Manufacturing Environment | Fully Onsite | Hours: Mon-Thurs from 4am - 2pm

Job Description

Join our team as a QA Analyst, where your role will be pivotal in ensuring the success of our customers by maintaining quality through auditing, evaluation of raw materials, and supporting continuous improvement efforts.

Responsibilities

• Review Production Batch Records to maintain a world-class manufacturing control program with a focus on training and first-time accuracy.
• Ensure documentation records are accurate and compliant with GDP requirements.
• Maintain compliance with current SOPs, Work Instructions, and test procedures.
• Train personnel to improve compliance with regulatory and quality requirements.
• Provide technical, process direction, and training to manufacturing personnel.
• Utilize interpersonal skills to foster a culture of quality and increase quality awareness.
• Document and investigate deviations and out-of-specification (OOS) situations.
• Proactively update SOPs, Work Instructions, controlled forms, and test methods to support improvements and compliance.
• Ensure product quality specifications and customer standards are met and maintained.
• Complete approvals to run as needed and ensure quality events are properly documented and escalated for effective decision-making.
• Ensure products meet specifications prior to release and maintain current reference and product standards.
• Utilize data to focus improvement efforts and meet customer and regulatory requirements.
• Accurately record data (cGMP) and pertinent information.
• Document OOS situations, determine root cause, and suggest solutions to prevent recurrence.
• Maintain compliance with current regulatory expectations and practices (e.g., USP).
• Understand and maintain a culture of 'lean action' to eliminate waste throughout the department.
• Apply and utilize 'lean tools' to permanently implement improvements and institutionalize 5-S in all aspects of the department.
  
  

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field Or High School Diploma with GMP experience.
• 1-2+ years of experience in quality assurance from pharmaceutical, medical device, or cosmetics industries (consideration for food & beverage experience).
• Experience reviewing batch records and/or compounding records.S
  
  

Pay and Benefits

The pay range for this position is $25.00 - $29.00/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)
  
  

Workplace Type

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

Application Deadline

This position is anticipated to close on Jun 23, 2025.

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 due to a disability, please email [e-mail] for other accommodation options.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Business Consulting and Services

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