Bachelor’s degree in engineering, science, or similar. Candidate must have a minimum of 5-8 years of experience with qualification, protocol generation and execution in FDA-regulated companies. Responsibilities will require performing manufacturing process and equipment qualification activities for a global oral solid dosage pharmaceutical company.
• Knowledge and understanding of Pharmaceutical GxPs and excellent GMP documentation skills
• Must be high energy, self-directed and driven, and must be able to work independently or with little supervision with sense of urgency accomplishing each task assigned
• Ability to effectively interact with individuals at all levels
• Intermediate to advanced MS Word and Excel needed as well as TrackWise, SharePoint, and PDF creator software experience
• Excellent written and verbal communication skills
Headquartered in Chicago metropolitan area, Protocol Link is a leading project management and strategy consulting firm providing comprehensive regulatory affairs, cGMP compliance, quality assurance, and validation services to the FDA-regulated companies worldwide. Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment while striving to offer the best of both quality and efficiency. It's how we've been doing business since 1996. The right way.