QA Analyst (2nd Shift)

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

• Review production batch records to maintain a world-class manufacturing control program with a focus on training and first-time-right execution.
• Ensure documentation records are accurate and fully compliant with Good Documentation Practices (GDP).
• Verify compliance with current Standard Operating Procedures (SOPs), Work Instructions, and test procedures across the production environment.
• Train manufacturing personnel to improve compliance with regulatory and quality requirements and provide ongoing technical and process direction.
• Use strong interpersonal skills to help create and sustain a culture of quality and increase quality awareness throughout the facility.
• Document and investigate deviations and out-of-specification (OOS) situations, including root cause analysis and recommended corrective actions.
• Proactively update SOPs, Work Instructions, controlled forms, and test methods to support continuous improvement and regulatory compliance.
• Ensure product quality specifications and customer standards are consistently met and maintained to customer satisfaction.
• Complete approvals to run as needed and ensure quality events, such as deviations and non-conformances, are properly documented and escalated for timely decision-making.
• Confirm that products meet all specifications prior to release and ensure current reference and product standards are properly maintained.
• Update product specifications as needed in response to customer, process, or regulatory changes.
• Accurately record data and pertinent information in compliance with cGMP requirements.
• Use data to identify and resolve ongoing quality issues on the manufacturing floor, implementing permanent corrective actions.
• Document OOS situations, determine root causes, and suggest solutions to prevent recurrence of issues.
• Maintain compliance with current regulatory expectations and practices, including USP and FDA-related guidelines.
• Understand, promote, and maintain a culture of lean action within the department, focusing on waste elimination and process efficiency.
• Implement and maintain standards and processes that eliminate waste throughout the department.
• Apply lean tools to implement permanent improvements and institutionalize 5S (Sort, Straighten, Shine, Standardize, Sustain) in all aspects of the department.
• Spend the majority of time on the manufacturing floor ensuring equipment runs efficiently and verifying that the area is properly cleaned and maintained.
• Inspect bottles, labels, caps, production equipment cleanliness, and finished packaging, identifying defects and quality concerns.
• Serve as the primary quality resource on the production floor and in the warehouse, ensuring adherence to quality standards.
• Interact with production, warehouse, and other team members to determine quality needs, communicate issues, provide training, and deliver feedback.
• Work at a desk when not on the floor to review batch records, write protocols, and assist with investigations.
• Send professional emails in English to communicate quality issues, decisions, and updates to stakeholders.
• Enforce quality policies when needed, using sound judgment and confident communication.

Requirements

• 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.
• Hands-on experience working in a GMP environment with a strong understanding of cGMP principles.
• Practical knowledge of quality assurance in manufacturing industries, including pharmaceuticals, medical device, cosmetics, and/or food.
• Experience with CAPA (Corrective and Preventive Actions) processes and quality investigations.
• Familiarity with FDA-regulated environments and associated quality requirements.
• Ability to audit facilities, production lines, and documentation for compliance and quality standards.
• Strong attention to detail and consistency, especially in a fast-paced environment.
• Ability to stand and walk for 80–90% of the workday while performing inspections and floor-based quality activities.
• Ability to communicate clearly and professionally in written and spoken English.
• High level of integrity and sound judgment when enforcing policies and making quality decisions.
• Self-motivated with the ability to work independently while collaborating effectively with cross-functional teams.

Skills

• Working knowledge of drug manufacturing regulations, including cGMP and 21 CFR regulations.
• Experience conducting investigations and managing deviations in a regulated manufacturing environment.
• Demonstrated ability to multi-task and manage competing priorities, as verified by references.
• Strong sense of urgency and responsiveness to quality issues and production needs.
• Strong organizational skills with the ability to maintain accurate records and documentation.
• Experience with lean manufacturing concepts and tools, including 5S and waste elimination.
• Comfortable making outbound calls and speaking up to address issues and enforce policies.
• Ability to build positive working relationships and collaborate effectively with production, warehouse, and quality teams.

Schedule

• 2nd shift: Monday through Friday, 2:00 PM to 10:00 PM.
• New hires train on 1st shift (Monday through Friday, 6:00 AM to 2:00 PM) for approximately two weeks before transitioning to 2nd shift.
• Voluntary overtime on some Saturdays and possibly Sundays, depending on business needs.

Pay

$25.00 - $30.00/hour.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital insurance
• 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)

Work Environment

This role operates in a GMP manufacturing facility with exposure to a wide range of products, including beauty, bath and body, lip balms, skincare, sunscreens, cleaning detergents, and other consumer goods. The QA Analyst spends the majority of the time on the manufacturing floor and in the warehouse, standing and walking 80–90% of the workday to inspect equipment, cleanliness, packaging components, and finished products. When not on the floor, the QA Analyst works at a desk with a computer, reviewing batch records, writing protocols, sending professional emails, and assisting with investigations. The facility emphasizes lean practices, 5S, and continuous improvement.

Professional attire appropriate for a manufacturing and quality assurance environment is required.

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