Quality Assurance Assistant -1st Shift

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.

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

• A high school equivalent is required, an 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 able to maintain gowning qualification
• Strong verbal and written communication skills
• Technical writing and review ability

What's on Offer?

• A dynamic environment where talent and ambition can develop to its fullest
• An open and informal organization culture, where individuals need to have strong motivation and ability to work independently
• Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities
• Competitive salary
• Comprehensive benefits
• Performance package
• Ability to be part of an international leader in an expanding industry