Job Title: QA AnalystJob Description
This role aims to contribute to the success of our customers by ensuring quality through auditing the facility and production lines, evaluating raw materials, bulk, and finished products, and engaging in continuous improvement efforts.
Responsibilities
- Perform reviews of Production Batch Records to maintain a world-class manufacturing control program with a focus on training and first-time right.
- Ensure documentation records are accurate and comply with GDP requirements.
- Ensure 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 help create a culture of quality and increase quality awareness.
- Document and investigate deviations and out-of-specification (OOS) situations.
- Ensure SOPs, Work Instructions, controlled forms, and test methods are proactively updated 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.
- Ensure quality events (deviations, non-conformances, potential issues) are properly documented and escalated for efficient, effective decision-making.
- Ensure products meet specification prior to release.
- Maintain current reference and product standards.
- Update specifications as needed.
- Utilize data to focus improvement efforts to meet customer and regulatory requirements.
- Accurately record data (cGMP) and pertinent information.
- Use data to ensure ongoing quality issues on the floor are permanently resolved.
- Document OOS situations, determine root cause, and suggest possible solutions to prevent recurrence.
- Maintain compliance with current regulatory expectations and practices (e.g., USP).
- Understand and maintain a culture of 'lean action' within the department to live lean better than any organization.
- Implement and maintain standards and processes that eliminate waste throughout the department.
- Apply and utilize 'lean tools' to permanently implement improvements.
- Institutionalize 5-S in all aspects of the department (Sort, Straighten, Shine, Standardize, and Sustain).
Essential Skills
- Bachelor's degree in Chemistry, Biology, or related field.
- 1-2+ years of GMP experience from pharmaceutical, medical device, or cosmetics.
- Experience reviewing batch records and/or compounding records.
Additional Skills & Qualifications
- Working knowledge of cGMP & 21CFR regulations.
- Experience with investigations & deviations.
- Attention to detail (verified by references).
- Ability to multi-task (verified by references).
Work Environment
Position is based out of the Eden Prairie site, spending the majority of time on the manufacturing floor to ensure equipment is running efficiently and the floor is properly cleaned. When not on the floor, the role involves working in a desk environment to review batch records, write protocols, and assist with investigations. Working hours are Monday to Thursday, 4am-2pm, with an option for voluntary overtime on Fridays.
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 May 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 (%) for other accommodation options.