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.

Bachelor's 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.