Quality Assurance Specialist (Tarrytown, NY)

Prestige Consumer Healthcare is a company that focuses on product innovation and quality in the over-the-counter healthcare and women’s health categories to better improve the lives of our customers and their world. For generations, our trusted brands have helped consumers care for themselves and their loved ones. We are the largest independent provider of over-the-counter products in North America, and we are constantly improving and creating products that match the ever-changing lifestyles and needs of people and families everywhere.

JOB SUMMARY: 
The Quality Assurance (QA) Specialist holds a key position in our Quality Department supporting QA managers in achieving and maintaining compliance for OTC drug products, medical devices, dietary supplements, and cosmetics. The individual must be data driven/analytical and able to develop and maintain effective working relationship with external suppliers and internal team members.

Essential Responsibilities (Include, but are not limited to): 

• Working closely with QA Manager in creating and maintaining product profiles, obtaining and reviewing stability data to help identify trends, and reviewing investigation reports.
• Prepare reports by collecting, analyzing, and summarizing data such as complaints, nonconformance reports, deviations, investigations, and corrective action preventative action (CAPA).
• 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. 
• Coordinate with third parties in creating and maintaining product profiles to 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. 
• 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. 
• Help establish product specifications following ICH & regulatory guidelines.

Requirements:             

• Bachelor's degree in 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:

Successful candidate will have -  

• 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

Travel: 15% ability to travel via car, plane, rail.

LANGUAGE SKILLS: 

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

MATHEMATICAL SKILLS: 

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. 

REASONING ABILITY: 

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. 

PHYSICAL DEMANDS: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

While performing the duties of this job, the employee is regularly required to sit. The employee frequently is required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus. 

WORK ENVIRONMENT: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

The noise level in the work environment is usually moderate. 

No Sponsorship: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

#HybridWork: We follow a Hybrid work schedule in office Tues/Wed/Thurs (remote on Mon/Fri), but this position must be flexible with business need demands and may be required to work in office Monday and/or Friday (e.g., Audits) . 

Salary range: $75k to $80k 

Work Hours: 40 hours per week.