Quality Assurance Specialist

Quality Assurance Specialist Within Pharma/Medical Device

Hours:

2pm - 10pm | Offers Benefits | Long-Term Opportunity

The Quality Assurance Specialist ensures product and process quality within a GMP manufacturing environment by auditing facilities and production lines, reviewing batch records, evaluating raw materials, bulk, and finished products, and driving continuous improvement. This role serves as a key quality resource on the manufacturing floor, supporting world-class manufacturing controls, regulatory compliance, and a strong culture of quality and lean practices.

Responsibilities

• Serve as the primary Quality resource for manufacturing and warehouse operations, ensuring products consistently meet customer, regulatory, and company quality standards.
• Review batch records, production documentation, and product specifications to ensure accuracy, compliance with cGMP and Good Documentation Practices (GDP), and first-time-right execution.
• Partner closely with production teams on the manufacturing floor to promote quality awareness, provide technical guidance, and support efficient, compliant operations.
• Lead investigations into deviations, non-conformances, and out-of-specification (OOS) events, conducting root cause analysis and implementing effective corrective and preventive actions.
• Drive continuous improvement initiatives by updating SOPs, work instructions, controlled documents, test methods, and product specifications to align with evolving regulatory and business requirements.
• Leverage data and Lean methodologies to identify quality trends, eliminate waste, improve processes, and sustain 5S and operational excellence initiatives.
• Perform in-process and final product inspections, verifying equipment cleanliness, packaging quality, and adherence to established product and quality specifications.
• Train and mentor employees on quality systems, regulatory expectations, and best practices while confidently communicating quality decisions and ensuring timely escalation of critical quality concerns.

Additional Skills & Qualifications

• Working knowledge of drug manufacturing regulations, including cGMP and 21 CFR regulations.
• Bachelor's degree in Chemistry, Biology, or a related scientific field.
• 1–2 years of experience in a GMP manufacturing environment such as pharmaceuticals, medical device, cosmetics, or food manufacturing.
• Experience reviewing batch records and/or compounding records.
• Experience conducting investigations and managing deviations in a regulated manufacturing environment.

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 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.

Final date to receive applications

This position is anticipated to close on Aug 9, 2026.