Quality Assurance Assistant

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

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

Requirements

• 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 maintain gowning qualification
• Strong verbal and written communication skills
• Technical writing and review ability

Benefits

• Competitive salaries
• 401(k) plan with company matching contribution
• Medical, vision, and dental coverage
• 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.