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

We offer a dynamic environment where talent and ambition can develop to its fullest. We have 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. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

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.

Fagron US is proud to be an affirmative action and equal opportunity employer.