QA Associate — GMP Compliance & Continuous Improvement

bimeda; Le Sueur (MN); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Health Insurance (medical, dental, etc

401(k) plan

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda is seeking a QA Associate to support the quality assurance program in GMP environments, including change control, release of materials and finished products, deviation investigations, and QA documentation. The role involves coaching operators on proper documentation practices and ensuring cGMP compliance across manufacturing.

Reporting to QA supervision, you will participate in audits, maintain SOPs, and drive continuous improvement while coordinating with production and QA teams to

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 use of computer applications and programs such as Microsoft Office, Excel and PowerPoint
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative
• 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 deviations on product quality and release status (release, reject, or hold)
• Conduct incoming inspection of printed roll-stock, labels, inserts, and cartons using sampling plans
• Interact with label vendors to resolve problems
• Investigate products, deviations, and OOS results to determine root cause and CAPA
• Perform internal quality audits compliant with policies
• Promote quality achievement and performance improvement across the organization
• Ensure ongoing compliance with local, national, and international standards and legislation
• Support audits/inspections (HPRA, FDA, customers) and ensure corrective actions are completed
• Inspect packaging lines for SOP compliance and assist with resolution of manufacturing issues
• Write, review, and revise SOPs and related forms
• Support Continuous Improvement program
• Review batch documentation for cGMP compliance with production
• Perform QA release of finished product and manage batch documentation
• Prepare raw materials and finished product samples for QA laboratory and monitor testing/documentation
• Inform management of discrepancies and identify root causes and countermeasures

Skills

Attention to detail

Analytical thinking

Cross-functional communication

Microsoft Office

Education

Bachelor’s degree in science

Tools

Excel

PowerPoint

Job description

Bimeda is seeking a QA Associate to support the quality assurance program in GMP environments, including change control, release of materials and finished products, deviation investigations, and QA documentation. The role involves coaching operators on proper documentation practices and ensuring cGMP compliance across manufacturing.

Reporting to QA supervision, you will participate in audits, maintain SOPs, and drive continuous improvement while coordinating with production and QA teams to