Clinical Quality Assurance Rep
Posted 6
views
Summary
A clinical quality assurance role in Indianapolis performing incoming sample inspection for batch release at a pharmaceutical company: ensuring cGMP/FDA and packaging/labeling compliance, overseeing controlled-substance sample handling, and serving as QA Data Steward for reserve samples in SAP.
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.