Quality Associate (Pharm) - GMP & Batch Records Expert

Hawkins Inc.; Minneapolis (MN); On-site; USD 33,000 - 34,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) match

Employee stock purchase program

Paid time off

Paid holidays

Job summary

Hawkins Inc. seeks a Quality Associate (Pharm) to support enterprise-wide quality efforts, ensuring product safety, quality and regulatory compliance across manufacturing and distribution.

You will coordinate qualification activities with internal and external resources to sustain and improve the Quality Management System. Responsibilities include issuing and reconciling regulated docs, performing line clearance, ensuring SOP adherence, and contributing to investigations.

Qualifications

• 4-year degree in a science-related field with a minimum of 1 year in an FDA-regulated industry
• Training and knowledge of cGMP regulations
• Proficient in documentation generation and review
• Able to juggle multiple priorities with minimal supervision

Responsibilities

• Issue, track, and reconcile regulated documentation (batch records, labels, logbooks) to production lines
• Perform line clearance and post checks to support manufacturing
• Verify alignment of activities with SOPs and regulatory requirements
• Identify and report quality events, deviations, or non-conformances
• Support investigations and implement process changes to improve quality

Skills

cGMP compliance

Documentation

Time management

Communication

Independent work

Education

Bachelor’s degree in science

High School diploma + 2 years FDA-regulated experience

Job description

Hawkins Inc. seeks a Quality Associate (Pharm) to support enterprise-wide quality efforts, ensuring product safety, quality and regulatory compliance across manufacturing and distribution.

You will coordinate qualification activities with internal and external resources to sustain and improve the Quality Management System. Responsibilities include issuing and reconciling regulated docs, performing line clearance, ensuring SOP adherence, and contributing to investigations.