Quality Assurance Assistant: GMP Compliance & Documentation

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 42,000 - 56,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision, and dental insurance

Health Savings Account (HSA)

Holiday/paid time off

Job summary

Fagron Sterile Services US (FSS) is seeking a Quality Assurance Assistant in Wichita, KS to ensure GMP-compliant manufacturing processes and to serve as reviewer/approver for required documentation in a plant setting.

The role is project-oriented with changing priorities and responsibilities, requiring experience in manufacturing or laboratory environments and proficiency in technical writing and review. Collaboration across teams is essential to maintain quality across multiple ongoing projects.

Qualifications

• High School diploma or equivalent; science degree preferred.
• Experience in manufacturing or laboratory setting.
• Experience in regulated environments (cGMP).
• Detail oriented with strong communication skills.
• Ability to work independently and with multiple departments.
• Ability to multitask and manage changing priorities.
• Cleanroom gowning trained or able to obtain qualification.
• Technical writing and document review experience.

Responsibilities

• Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance.
• Support manufacturing through timely processing of deviations, change controls, CAPA, complaints handling, and investigations to ensure quality products.
• Conduct facility and/or 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

Detail oriented

Strong verbal and written comm.

Independent and interdepartmental coll

Multitasking

Education

Associate or Bachelor's degree in science-related field

High School diploma or equivalent

Job description

Fagron Sterile Services US (FSS) is seeking a Quality Assurance Assistant in Wichita, KS to ensure GMP-compliant manufacturing processes and to serve as reviewer/approver for required documentation in a plant setting.

The role is project-oriented with changing priorities and responsibilities, requiring experience in manufacturing or laboratory environments and proficiency in technical writing and review. Collaboration across teams is essential to maintain quality across multiple ongoing projects.