CGMP Quality Assurance Associate: Documentation

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

Benefits offered by this job

Health coverage

Retirement matching contributions

Paid time off

Professional development opportunities

Employee wellness programs

Employee Assistance Program

Job summary

Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch review, and final disposition in manufacturing and packaging operations. This role emphasizes rigorous documentation and adherence to quality procedures within FDA-regulated processes.

The position also involves investigations, document lifecycle administration, and collaboration with Operations to ensure compliance. ASQ CQI/CQA certification is a plus for the candidate pool.

Qualifications

• High School diploma or equivalent with 3 years of FDA-regulated industry experience.
• Associate degree (technical field) with 1 year of experience orBachelor's degree (technical field) with no experience accepted.
• Experience in a cGMP production environment with documentation generation and review.
• Experience in conducting and documenting investigations is a plus.

Responsibilities

• Issues cGMP batch records and logbooks to operations and ensures documentation accuracy.
• Review executed batch records with operations to resolve issues.
• Perform final batch disposition.
• Administer document lifecycle functions and adherence to procedures.
• Assist in investigations and recommend documentation resolutions.
• Participate in special projects assigned by QA Management.

Skills

Documentation

Auditing

Attention to detail

Communication skills

Independent work

Education

High School diploma

Associate degree in technical field

Bachelor's degree in technical field

Tools

ASQ certification (CQA)

Job description

Bora Pharmaceuticals is seeking a Quality Associate to support cGMP documentation, batch review, and final disposition in manufacturing and packaging operations. This role emphasizes rigorous documentation and adherence to quality procedures within FDA-regulated processes.

The position also involves investigations, document lifecycle administration, and collaboration with Operations to ensure compliance. ASQ CQI/CQA certification is a plus for the candidate pool.