Clinical Quality Assurance Rep

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.