Quality Assurance Assistant -1st Shift

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

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.