Quality Assurance Specialist

4 days ago

Tarrytown, New York, United States Emerge Talent Cloud Full time
Job Overview

Prestige Consumer Healthcare is a leading company in the over-the-counter healthcare and women's health categories, focusing on product innovation and quality to improve the lives of customers and their families. We are the largest independent provider of over-the-counter products in North America, constantly improving and creating products that meet the evolving needs of people and families.

Key Responsibilities
  • Collaborate with QA Managers to ensure compliance for OTC drug products, medical devices, dietary supplements, and cosmetics.
  • Develop and maintain effective working relationships with external suppliers and internal team members.
  • Prepare reports by collecting, analyzing, and summarizing data on complaints, nonconformance reports, deviations, investigations, and corrective action preventative action (CAPA).
  • Support 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.
  • Coordinate with third parties to create and maintain product profiles, including stability protocols, laboratory methods, master batch records, product specifications, method validations, process/packaging and cleaning validation protocols and reports.
  • Protect the organization's competitiveness by keeping information confidential.
  • Achieve organizational goals by accepting ownership for accomplishing new and different requests, exploring opportunities to add value to job accomplishments.
  • Help establish product specifications following ICH & regulatory guidelines.
Requirements
  • Bachelor's degree in a scientific or engineering discipline (Chemistry – strongly preferred).
  • Minimum of 3 years of relevant work experience.
  • Working knowledge of cGMP requirements.
  • Previous internship in a quality department, Chemistry laboratory, or formulation experience – A Plus.
Success Profile
  • 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 managing multiple responsibilities, while staying organized, attentive to details, and working with a consistent sense of urgency.
  • Ability to interpret and analyze information.
  • Excellent verbal, interactive communication skills, and effective interpersonal skills.
  • Excellent writing skills (must be able to write comprehensive reports, emails, minutes, memos, etc. with minimal need for editing/proofing).
  • High proficiency in computer skills: Microsoft Office, Excel, Adobe, Word.
Work Environment

The work environment is moderate, with a focus on quality and compliance. The successful candidate will be able to work effectively in a team environment, communicate clearly, and maintain confidentiality.

Salary range: $75k to $80k. Work hours: 40 hours per week. Hybrid work schedule: 3 days in office, 2 days remote. Ability to travel 15% of the time via car, plane, or rail.

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