GMP QA Associate: Quality, Compliance & Release

Bimeda; Le Sueur (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan for retirement savings

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda is seeking a QA Associate to support quality assurance across GMP areas. You will participate in change control, material release, deviation resolution, and cGMP training to ensure compliance during manufacturing. You will coach operators on proper documentation while supporting continuous improvement initiatives.

The role involves reviewing batch records, assisting with QA release, and maintaining SOPs. A Bachelor’s degree in a related science and 1+ years of QA experience are preferred.

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.

Responsibilities

• Assess potential impact of incidents and processing deviations on product quality and release status.
• Conduct incoming inspection of printed materials to determine acceptability.
• Investigate product complaints, deviations, and OOS 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.
• Participate in audits/inspections and ensure corrective actions are completed.

Skills

Microsoft Office

Excel

PowerPoint

Attention to detail

Analytical thinking

Cross-functional collaboration

Education

Bachelor’s degree in a related Science or equivalent experience

Job description

Bimeda is seeking a QA Associate to support quality assurance across GMP areas. You will participate in change control, material release, deviation resolution, and cGMP training to ensure compliance during manufacturing. You will coach operators on proper documentation while supporting continuous improvement initiatives.

The role involves reviewing batch records, assisting with QA release, and maintaining SOPs. A Bachelor’s degree in a related science and 1+ years of QA experience are preferred.