Clinical Quality Assurance Rep needs GMP pharmaceutical and 2+ years experience Clinical Quality Assurance Rep requires: • Strong knowledge of cGMPs, Quality Systems and FDA Regulations. • Bachelors degree in a science related field and/or relevant experience in a pharmaceutical GMP environment • Ability to work across functional areas with people of all levels of the organization. • Strong oral and written communication skills. • Demonstrated interpersonal and networking skills. • Ability to gather, edit, organize, and summarize information from multiple sources including databases, websites, site interviews and audits. • Must exhibit attention to detail. • Ability to work under time pressure with proven demonstration of good judgment in making decision under minimum supervision. • Excellent teamwork and interpersonal skills. Clinical Quality Assurance Rep duties: • Perform incoming sample inspection for batch release. Ensure product packaging and labeling compliance, including maintaining Clinical Trial blinding requirements, for a variety of product types, • Provide oversight for sample management to ensure compliance for the handling of Special Security Substances (SSS) and controlled substances. • Obtain authorization to handle Controlled Substances (CS) • Provide consultation and interpretation of local procedures, corporate standards and regulatory expectations that apply to sample management. • Serve as the QA Data Steward for reserve sample lots created in SAP.