Quality Assurance Assistant -1st Shift

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.

About the Role

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.

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

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.