GMP Quality Assurance Assistant — Dynamic, Multitask Role

Fagron Tech; Wichita (KS); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, Vision and Dental

Health Savings Account (HSA)

Holiday/Paid time off

Job summary

Fagron is seeking a Quality Assurance Assistant to ensure GMP compliance in a manufacturing plant. The role involves reviewing lab data, batch records, and change controls while supporting deviations, CAPA, and investigations. You’ll work in a project-driven environment with shifting priorities.

Ideal candidates have a high school equivalency, with a science-related degree preferred, and experience in regulated settings. Strong writing and communication skills are essential.

Qualifications

• High School equivalent is required; a science-related degree is preferred.
• Experience in manufacturing or laboratory settings.
• Work in a regulated environment (cGMP) is expected.
• Detail oriented with strong documentation practices.
• Ability to work independently and across departments.
• Ability to multitask across multiple projects and priorities.
• Cleanroom gowning training and maintaining qualification.
• Strong verbal and written communication skills.
• Technical writing and document review ability.

Responsibilities

• Review lab data, validation and stability protocols and batch records for compliance.
• Support manufacturing through timely processing of deviations, CAPA and investigations.
• Conduct facility and supplier assessments, raw material release, and line clearances.
• Author and update SOPs as needed.
• Follow GMP guidelines and SOP/GMP requirements.
• Communicate QA issues to staff and managers clearly.
• Manage multiple projects with changing deadlines and priorities.

Skills

Detail oriented

Verbal communication

Written communication

Technical writing

Multitasking

Independent work

Education

High School equivalency

Associate or Bachelor's degree in science-related field

Job description

Fagron is seeking a Quality Assurance Assistant to ensure GMP compliance in a manufacturing plant. The role involves reviewing lab data, batch records, and change controls while supporting deviations, CAPA, and investigations. You’ll work in a project-driven environment with shifting priorities.

Ideal candidates have a high school equivalency, with a science-related degree preferred, and experience in regulated settings. Strong writing and communication skills are essential.