Manufacturing QA Specialist: Quality & Compliance

Actalent; Minnesota; On-site; USD 28,000 - 39,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan – Pre-tax and R

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent is seeking a Quality Assurance Specialist to support production quality and ensure regulatory compliance on the manufacturing floor in Chanhassen, MN. You will create and manage work orders, maintain documentation, and address quality concerns to drive continuous improvement.

The role requires 1–3 years of QA experience in a regulated setting, familiarity with FDA/GMP/GDP standards, and strong attention to detail. Onsite work with full benefits and consistent shift timing.

Qualifications

• 1–3 years of quality assurance experience in manufacturing or regulated environments.
• Experience with FDA regulations and GMP/GDP standards.
• Familiarity with inspection tools (micrometers, calipers, gauges).
• Strong attention to detail, organization, and multitasking.
• Proficiency in Microsoft Word and Excel.

Responsibilities

• Create and manage work orders and fill documentation aligned to the production schedule.
• Maintain retains, including collection, tracking, organization, and storage.
• Issue deviations and partner with QA to resolve issues.
• Address on-floor and QC inspection concerns, such as labeling, placement, and quality issues.
• Inspect and approve incoming components and evaluate questionable parts, escalating as needed.
• Establish and train on sensory standards for finished goods.
• Review batch records and provide a second sign-off.
• Complete changeover documentation for production runs.
• Maintain accurate records and tracking systems.
• Drive continuous improvement by identifying issues and reinforcing quality standards.

Skills

QA experience

Regulatory knowledge

Inspection tools familiarity

Attention to detail

MS Office

Communication skills

Adaptability to schedules

Education

Associate or technical degree

Job description

Actalent is seeking a Quality Assurance Specialist to support production quality and ensure regulatory compliance on the manufacturing floor in Chanhassen, MN. You will create and manage work orders, maintain documentation, and address quality concerns to drive continuous improvement.

The role requires 1–3 years of QA experience in a regulated setting, familiarity with FDA/GMP/GDP standards, and strong attention to detail. Onsite work with full benefits and consistent shift timing.