QA Associate: GMP Quality & Batch Release (Afternoon)

Mennonite Economic Development Associates (MEDA); Le Sueur (MN); On-site; USD 50,000 - 75,000; Full time

Benefits offered by this job

Health Insurance (medical, dental, and

401(k) plan for retirement savings

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda is seeking a QA Associate to join its Quality Assurance team. Reporting to the QA Supervisor, you will support GMP compliance, change control, product release, and ongoing quality improvement across manufacturing operations.

You will train operators on documentation practices, participate in audits, and help ensure regulatory adherence while collaborating with cross-functional teams. Afternoon shift available, with a focus on packaging and labeling controls.

Qualifications

• Minimum 1+ years of direct work experience with pharmaceutical or food manufacturing Quality Assurance systems, regulations, guidelines, and associated standards.
• Training and knowledge of cGMP regulations.
• Extremely detail-oriented and analytical thinker with strong problem-solving ability.
• Able to develop, review, and maintain metrics and quality audits.
• Able to interface directly with cross-functional teams.
• Proficiency in Microsoft Office, Excel and PowerPoint.
• High integrity, excellent attention to detail, analytical thinker, organize and prioritize, and work in a team environment.
• Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal supervision.
• Strong work ethic and positive team attitude.

Responsibilities

• Assess potential impact of incidents and processing deviations on product quality; perform batch record review and determine batch status.
• Conduct incoming inspection of printed labelling using statistical sampling to determine acceptability.
• Interact with label vendors if problems exist.
• Investigate product complaints, deviations, and OOS results to determine root cause and corrective actions.
• Perform internal quality audits compliant with corporate policies and procedures.
• Promote and advocate quality achievement and performance improvement across the organization.
• Ensure ongoing compliance with local, national, and international standards and legislation.
• Participate in HPRA, FDA, and customer audits/inspections and ensure corrective actions are completed.
• Perform initial inspection of packaging lines to ensure SOP compliance.
• Assist with resolution of compliance issues related to manufacturing lines and SOPs.
• Write, review, and revise SOPs and related forms.
• Support Continuous Improvement program throughout the company.
• Review batch documentation for cGMP compliance and resolve discrepancies with production.
• Perform QA release of finished product for acceptable materials; manage pallet tagging and filing.
• Prepare raw materials and finished product samples for QC and monitor testing documentation.

Skills

QA experience

cGMP knowledge

Detail-oriented

Cross-functional collaboration

MS Office

Integrity

Multi-tasking

Teamwork

Education

Bachelor’s degree in a related Science

Job description

Bimeda is seeking a QA Associate to join its Quality Assurance team. Reporting to the QA Supervisor, you will support GMP compliance, change control, product release, and ongoing quality improvement across manufacturing operations.

You will train operators on documentation practices, participate in audits, and help ensure regulatory adherence while collaborating with cross-functional teams. Afternoon shift available, with a focus on packaging and labeling controls.