Quality Assurance Specialist

About the role

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.

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.
• Cook up 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.
• Protect organization's competitiveness by keeping information confidential.
• 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).

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• The noise level in the work environment is usually moderate.
• No reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.