Job Description
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.
Employment Type: Full-Time
Salary: $ 24.00 Per Hour
Job Tags
Hourly pay, Full time, Local area,