QA Analyst (2nd Shift)

QA Analyst (2nd Shift)

As a QA Analyst, you will play a crucial role in ensuring quality and compliance through auditing, evaluating materials, and driving continuous improvement efforts. Your contribution will directly impact the success of our customers by maintaining high-quality standards in our facility and production lines.

Responsibilities

• Perform reviews of Production Batch Records to maintain a world-class manufacturing control program.
• Ensure documentation records are accurate and compliant 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 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 document quality events 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 resolve ongoing quality issues on the floor.
• Document OOS situations, determine root causes, and suggest solutions to prevent recurrence.
• Maintain compliance with current regulatory expectations and practices.
• Implement and maintain standards and processes to eliminate waste throughout the department.
• Apply and utilize lean tools to permanently implement improvements.
• Institutionalize 5-S in all aspects of the department.

Essential Skills

• Experience in a GMP manufacturing environment 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.
• GMP, batch record, Quality Assurance within the specified industries.

Additional Skills & Qualifications

• Working knowledge of drug manufacturing regulations such as cGMP & 21CFR regulations.
• Experience with investigations and deviations.
• Strong attention to detail.
• Ability to multi-task.
• Strong sense of urgency.
• Strong organizational skills.
• Highly self-motivated with the ability to work independently.
• Confident communicator comfortable with making outbound calls and enforcing policies.

Work Environment

This position requires working the 2nd shift from 2 PM to 10 PM, Monday through Friday, at the Eden Prairie site. You will spend the majority of your time on the manufacturing floor ensuring equipment runs efficiently and the area is properly cleaned. The role also involves desk work for reviewing batch records, writing protocols, and assisting with investigations. Initial training will be conducted on the 1st shift, Monday to Friday from 6 AM to 2 PM for two weeks. There may be opportunities for voluntary overtime on Saturdays and possibly Sundays.

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 $26.00 - $28.00/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 26, 2026.