Quality Assurance Specialist

Prestige Brands•Clayton, IN

3d•$65,000 - $80,000•Onsite

About The Position

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 Specialist will hold a key position in the Science & Technology Department. The individual is responsible for advanced Quality Assurance activities, including quality systems support, investigations, auditing, compliance reporting, and continuous improvement initiatives. The Specialist will provide on-the-ground quality oversight at our third-party logistics provider location in Clayton, IN, and serve as a technical quality resource to ensure GMP compliance through the development, execution, and continuous improvement of Quality Assurance programs. This is a senior individual contributor role with no direct reports.

Requirements

Bachelor's degree in Life Sciences, Chemistry, Biology, Quality, Engineering, or a related discipline preferred.
Knowledge of FDA 21 CFR Parts 111, 210 and 211 and applicable cGMP pharmaceutical quality requirements
Minimum of 3-5 years of Quality Assurance experience in a GMP-regulated pharmaceutical, medical device, consumer healthcare, manufacturing, warehousing, or distribution environment.
Experience conducting investigations, managing CAPAs, supporting supplier quality activities, auditing, and quality systems preferred.
Working knowledge of quality systems, including CAPA, deviations, change control, audits, and document control.
Previous experience with quality and packaging inspections
Experience with SAP or other ERP systems in a GMP environment.
Ability to analyze quality data, identify trends, assess compliance risks, and recommend appropriate corrective actions.
Knowledge of FDA cGMP for Warehousing and Distribution, Packaging and Labeling, and Returned and Salvaged Products
Knowledge of ISO 13485:2016
Good verbal and written communication skills are required.
Proficiency in computer skills, Microsoft Office applications (Excel/Word)
Efficient and attentive to detail
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.
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.
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.

Responsibilities

Assumes responsibility for establishing and maintaining effective, coordination, communication and professional business relations with suppliers, company personnel, management and 3PL.
Lead nonconformance investigations, perform root cause analysis, recommend corrective and preventive actions (CAPAs), and monitor effectiveness through closure.
Oversee and inspect rework/re-label operations to correct nonconformances and ensure activities are completed in accordance with approved procedures.
Coordinate and lead assigned supplier audit activities, including audit preparation, management of supplier responses, evaluation of corrective actions, identification of quality system improvements, and audit closure activities.
Complete and maintain related inspection reports and documentation in an organized and retrievable manner.
Draft, revise, and maintain SOPs, work instructions, and quality system documentation to support GMP compliance and operational excellence at 3PL facilities.
Analyze quality trends, recurring deviations, inspection findings, and quality metrics to identify opportunities for continuous improvement.
Monitor CAPA, deviation, audit, and supplier corrective action commitments to ensure timely completion and effectiveness.
Serve as the primary quality resource for assigned warehouse operations and provide guidance regarding GMP, quality system, and compliance requirements.
Review quality metrics and prepare reports summarizing key quality performance indicators, trends, risks, and improvement opportunities.
Support supplier qualification, supplier performance monitoring, and ongoing supplier quality management activities.
Provide technical guidance and training to Quality Inspectors and cross-functional business partners regarding quality processes, GMP requirements, and quality system expectations.
Participate in internal audits, supplier audits, regulatory inspections, and quality system assessments as required.
Partner with Supply Chain, Operations, Regulatory Affairs, and Quality leadership to resolve quality issues and implement corrective actions.
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.
Perform and oversee inspection and transactional Quality Assurance activities supporting 3PL operations, including receipt inspections, SAP status transactions, pallet verification activities, transaction and exception report review, product disposition decisions, and supplier documentation review and follow-up.