Quality Assurance Associate – cGMP & Documentation

Bora Pharmaceuticals Inc; Maple Grove (MN); On-site; USD 52,000 - 67,000; Full time

Benefits offered by this job

Salary & incentives

Health coverage

Retirement plan

Paid time off

Professional development

Wellness programs

EAP & mental health resources

Job summary

Bora Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch record review, and QA approvals in a regulated manufacturing environment. You will handle document lifecycle and assist with investigations under QA Management. Experience in FDA-regulated settings is required.

Preferred ASQ certification, strong attention to detail, and ability to work with operations to drive compliance and quality improvements.

Qualifications

• Interpersonal, auditing, and proofreading skills required.
• Attention to detail and ability to work independently or in a team.

Responsibilities

• Issues cGMP batch records and logbooks to operations.
• Review executed manufacturing and packaging batch records for accuracy.
• Perform document lifecycle administration and ensure compliance with procedures.
• Assist Operations and QA Management in investigations and resolutions.

Education

High School diploma or equivalent with 3 years FDA-regulated industry experience

Associate degree in Chemistry/Engineering or related field with 1 year experience

Bachelor's degree in a technical field with no experience

Tools

ASQ Certification (CQA/CQI/CQIA)

Job description

Bora Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch record review, and QA approvals in a regulated manufacturing environment. You will handle document lifecycle and assist with investigations under QA Management. Experience in FDA-regulated settings is required.

Preferred ASQ certification, strong attention to detail, and ability to work with operations to drive compliance and quality improvements.