GMP QA Associate - Quality, Audits & Compliance

Bimeda, Inc.; Minnesota; On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k) plan for retirement savings

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda, Inc. in Minnesota is seeking a QA Associate to join a GMP-driven Quality Assurance team. The role covers change control, facility compliance, product and material release, deviation resolution, and ensuring cGMP standards are met.

You will coach operators on proper documentation practices to ensure manufacturing compliance. Requirements include 1+ year in pharmaceutical or food QA, cGMP knowledge, and a bachelor’s degree in a related science.

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.

Responsibilities

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

Skills

QA Experience

cGMP knowledge

Analytical thinking

Detail oriented

Cross-functional interfacing

Excel

Education

Bachelor’s degree in a related Science

Tools

Microsoft Office

Excel

PowerPoint

Job description

Bimeda, Inc. in Minnesota is seeking a QA Associate to join a GMP-driven Quality Assurance team. The role covers change control, facility compliance, product and material release, deviation resolution, and ensuring cGMP standards are met.

You will coach operators on proper documentation practices to ensure manufacturing compliance. Requirements include 1+ year in pharmaceutical or food QA, cGMP knowledge, and a bachelor’s degree in a related science.