Position

Quality Assurance Specialist (Tarrytown, NY)


Department:

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.

Major Responsibilities/Activities

  • 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.

Qualifications:

  • 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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