Quality Assurance Generalist (Mon-Fri 10a-6:30p)

About the role

Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions. If you would like to be part of such an important challenge and feel you would thrive among dedicated and passionate colleagues, then chances are you will discover a career at Fagron that you'll love!

Key Responsibilities

• Support execution of product Batch Records and associated manufacturing and Quality related systems for the compounding processes.
• Ensure day-to-day compliance to all requirements established for compounded product and the systems supporting compounding.
• Aid with problem identification and resolution efforts for quality related issues associated with the compounding operations.
• Review and approve manufacturing batch records, labels and other batch related documentation.
• Aid with internal, corporate, 3rd party and federal/state inspections and audits.
• Provide contributing information on measures of local quality system effectiveness such as right the first time, documentation errors and others as assigned.
• Participate in QA meetings for Product manufacturing and Media Fill execution.
• Ensure cGMP documentation associated with work activities is complete.
• Perform other related duties as assigned.

Qualifications

• College Degree or a High school diploma or equivalent with cGMP experience in a pharmaceutical manufacturing company (or similar) required.
• Experience with aseptic technique, cGMP document review and MasterControl preferred.
• Proficient in MS Office programs, including Word and Excel.
• Ability to work in a fast-paced environment.
• Ability to handle a high volume of work and rapidly adapt to changing environment.
• Ability to work with others in a positive and professional manner and to develop and maintain strong working relationships with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, and accountability.

Pay

$55,000-$70,000 USD Annually

What's on Offer?

• 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.