Quality Assurance Specialist (Tarrytown, NY)
Quality and Regulatory Affairs
The Quality Assurance (QA) Specialist supports QA managers in achieving and maintaining compliance for OTC drug products, medical devices, dietary supplements, and cosmetics. This is a data driven/analytical person who is able to develop and maintain effective working relationships with external suppliers and internal team members. This is an entry level position for a 4-year college graduate in the sciences or engineering fields.
- Prepare reports by collecting, analyzing, and summarizing regulatory and compliance data and trends such as stability, complaints, nonconformance reports, deviations, investigations, and corrective action preventative action (CAPA).
- Prepare implementation plans and timelines for QA Manager’s approval.
- Support the Good Manufacturing Practices (GMP) audits under the direction of the QA Manager
- Foster close cooperative relationships with all functions in the company relative to quality and GMP compliance.
- Analyze data & propose corrective actions to the QA Manager and to Contractor. These include but are not limited to stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports. Ensures that product dossiers are maintained and kept current.
- Protects organization's competitiveness by keeping information confidential.
- Accomplishes organization goals by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
- BS in a Scientific or engineering discipline; previous college internship in a Quality Department helpful
- Demonstrated sound decision making process and scientific problem solving capabilities based on facts, data, and the application of risk management principles
- Proven track record of working independently and managing multiple responsibilities with a consistent sense of urgency
- Ability to analyze information
- Effective verbal and written communication skills and demonstrated interpersonal skills
- High proficiency in computer skills, Microsoft Office/Project
Travel: 15% ability to travel via car, plane, rail.
Prestige is an Equal Opportunity Employer
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