“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- Deviation/CAPA process and records working knowledge
- Experience with tools such as Trackwise, Teams, Smartsheet, Excel etc
- Medical device/Combination product experience
- Owning/QA for Deviation/CAPA records
- Deviation Trend analysis
- Interim timepoint checks for CAPA/EV records
- Automating data analysis using tools
3 must haves are extremely important-please be sure that candidates fit the requirements
Nonconformance, Deviation, CAPA process experience
Root cause analysis techniques
Data analysis and familiarity with CAPA management tools
As a member of this company's 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.