Quality Assurance Assistant -1st Shift

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.

• 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.

• 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.

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.

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.