Quality Assurance Assistant -1st Shift at Fagron

Who We Are

Since 1990, we’ve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics — we deliver smart, ready-to-use solutions that make healthcare better.

We’re passionate, science-driven, and always looking for new ways to improve lives.

Explore your future at Fagron Career Site.

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.