Logistics:
Base Salary Range: 100k-110k
Schedule: 5 days onsite, Mon-Friday
Required Skills & Experience:
- Experience handling Change controls/ Deviations/ Incidents/ CAPA/Risk Assessment/ Product Quality Complaints etc., which includes initiation to closure, effectiveness and trending.
- Understanding of DQRS (Drug Quality Reporting System) cases, coordinating with manufacturing sites for investigation and Regulatory Affairs for arranging more information/ samples from FDA.
- Experience handling Field Alert Reports and Product Recalls
- Experience complying to DSCSA (Drug Supply Chain Security Act)
- Experience handling Internal and External audit
- Experience handling controlled substances
Job Description
Insight Global is seeking an Associate Manager of Quality Compliance who is responsible for overall compliance of Quality systems, Standard Operating Procedures, CFR guidelines, DEA guidelines, DSCSA guidelines, Internal and External audits etc.