Minimum 8-10 years of pharmaceutical microbiology experience with expertise in developing and performing aseptic process simulations (media fills) and investigation of media failures. 100% travel flexibility required.
• Understanding of objectionable organisms in a variety of pharmaceutical products (e.g. injectable, oral, topical, implantable, etc.)
• Expertise with microbiology laboratory testing procedures and regulatory requirements
• In-depth knowledge of pharmaceutical clean room environmental monitoring for aseptic, terminally sterilized and non-sterile manufacturing environments
• Proficiency in the development of environmental monitoring programs (Static and Dynamic monitoring)
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.