Specialist 2, Quality Assurance

Description

The Quality Specialist II will be accountable to support Product Review reports and to support investigations pertaining to observations or trends discovered during data collection. The Quality Specialist II will also be accountable for supporting Laboratory Information Management System (LIMS) Master Data changes needed by the Quality Control Laboratory. Key Responsibilities: • Communicate to Quality Management the observations or trends discovered during the data collection and review of the Product Reviews. Maintain metrics and support management reviews and other presentations. • Support Product Review completion per scheduled timeline and store in document management system. • Fulfill LIMS Master Data requests. • Review Master Data submissions for accuracy and provide feedback as necessary. • Performs other duties, as assigned. Qualifications: • A minimum of a University/Bachelors Degree or higher is required. • A minimum of two (2) years related experience with Quality Control or Quality Assurance in Pharmaceutical, Medical Device, OTC Drug and/or Cosmetic production environment is required • Excellent analytical, prioritization, multi-tasking, communication, and strong leadership skills and the ability to work independently without supervision is required • Ability to work effectively on cross functional teams is required LIMS experience preferred