Bachelor’s Degree in the Life Sciences or Engineering field, or similar with 2-5 years of GMP experience with expertise in authoring fundamental Quality System SOPs for an FDA regulated company.
• Experience drafting new SOPs and editing existing SOPs to align with current practices
• Excellent writing and oral communication skills
• Ability to exercise judgment within defined procedures and practices to determine appropriate action with minimal supervision
• Maintain standardized language and documentation that allow for consistent execution of documents
• Advanced MS office skills including Word
• Well organized and detail oriented with the ability to handle multiple tasks
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.