Quality Assurance Assistant -1st Shift

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

About the Job

The Quality Assurance Assistant will ensure compliance of manufacturing processes in a GMP environment and will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project-oriented, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.

Key Responsibilities

• Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance.
• Support manufacturing through timely process of deviations, change controls, CAPA complaint 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.

Basic Qualifications

• High School equivalent is required, associate or bachelor's degree in a science related field is preferred.
• Experience working in a manufacturing or laboratory setting.
• Ability to work in a regulated environment (cGMP).
• Detail oriented.
• Ability to work both independently and interdepartmentally.
• Ability to multitask.
• Ability to be cleanroom gowning trained and ability to maintain gowning qualification.
• Strong verbal and written communication skills.
• Technical writing and review ability.

What’s on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution, medical, vision and dental, health savings account (HSA), holiday/paid time off.

At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We’re proud to be an equal opportunity employer. Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.