Quality Assurance Specialist

Prestige Brands; Clayton (IN); On-site; USD 65,000 - 80,000; Full time

Job summary

Prestige Consumer Healthcare is seeking a senior Quality Assurance Specialist to oversee GMP-compliant QA activities at a 3PL facility in Clayton, IN. The role supports quality systems, investigations, audits, CAPAs, and continuous improvement initiatives, acting as a technical quality resource without direct reports.

The position emphasizes collaboration with Supply Chain, Regulatory Affairs, and Quality leadership to resolve issues and ensure compliance across operations.

Qualifications

• 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 environment.
• Experience conducting investigations, managing CAPAs, supporting supplier quality activities, auditing, and quality systems preferred.

Responsibilities

• Establish and maintain effective coordination with suppliers, site personnel, management and 3PL.
• Lead nonconformance investigations and CAPA closure.
• Oversee rework/label operations to correct nonconformances.
• Coordinate supplier audits and evaluate corrective actions.
• Draft and maintain SOPs and quality documentation for GMP compliance.

Skills

Quality Systems

CAPA

Audits

SOPs

GMP

Education

Bachelor's degree in Life Sciences

Tools

SAP

Job description

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.

MAJOR RESPONSIBILITES/ACTIVIES:

• 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.

QUALIFICATIONS:

• 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

Essential Physical Functions:

• Basic office activities
• Approximately 60/40 split between active inspection work in the warehouse and office work. Exerts up to 40 lbs. of force occasionally (Ability to move cases from pallets for inspections and ability to walk back and forth from office to warehouse storage locations.)

Travel: 5% 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.

Work Schedule:

All applicants must be able to work in our Geodis Warehouse at designated hours – Monday through Friday. Work Hours: 40 hours per week.

Salary Range:

$65,000-$80,000