GMP Quality Assurance Associate - Documentation & Compliance

Fagron Group; Wichita (KS); On-site; USD 42,000 - 64,000; Full time

Benefits offered by this job

401(k) with company matching

Medical, vision and dental

Health savings account (HSA)

Paid holidays

Job summary

Fagron Group is seeking a Quality Assurance Assistant to ensure GMP compliance in manufacturing and to review/approve essential documentation in a plant setting. This project-driven role features evolving priorities and responsibilities daily.

You will review lab data, deviations, CAPA, and change controls, author and update SOPs, and communicate QA issues across teams while maintaining strict regulatory standards in Wichita, KS.

Qualifications

• High School diploma or equivalent required; science degree preferred.
• Experience in manufacturing or laboratory settings.
• Knowledge of cGMP and regulatory compliance.
• Detail-oriented with strong multitasking abilities.
• Able to work independently and cross-functionally.
• Strong written and verbal communication; technical writing skills.

Responsibilities

• Review lab data, validation and stability protocols for compliance.
• Process deviations, change controls, CAPA, complaint handling, and investigations in a timely manner.
• Conduct facility and supplier assessments, raw material release, and line clearances.
• Author and update SOPs as needed.
• Follow GMP guidelines and adhere to SOPs and GMP requirements.
• Communicate QA issues to employees and managers in a tactful manner.
• Work on multiple projects at once with changing deadlines and priorities.

Skills

Attention to detail

cGMP knowledge

Technical writing

Verbal and written communication

Multitasking

Independent work

Gowning trained

Regulatory compliance

Education

Associate or Bachelor's degree in a science-related field

Job description

Fagron Group is seeking a Quality Assurance Assistant to ensure GMP compliance in manufacturing and to review/approve essential documentation in a plant setting. This project-driven role features evolving priorities and responsibilities daily.

You will review lab data, deviations, CAPA, and change controls, author and update SOPs, and communicate QA issues across teams while maintaining strict regulatory standards in Wichita, KS.