Top 3 Must Have Skill Sets:
Nonconformance, Deviation, CAPA process experience
Root cause analysis techniques
Data analysis and familiarity with CAPA management tools
As a member of Commercial Quality group for drug delivery systems, the QA Specialist will provide quality engineering support for the product life cycle management and design control systems in the maintenance of commercialized drug delivery devices, combination products, and non-combination products.
Responsibilities include participation in the implementation of Design controls per FDA CFR 820.30, Corrective and Preventive action projects CFR 820.100, documentation related to investigation of product complaints, trending of quality data, and other assignments as given.
Manages low to moderate complexity programs with minimal supervision.
Participates in technical aspects of problem-solving, complaints, and other investigations in relevant design control phases. Participates in non-design control investigations on an as needed basis.
"This posting is for Contingent Worker, not an FTE"