Quality Assurance Manager

Life Science Logistics • Macungie, PA

1d

About The Position

The Quality Assurance Manager oversees quality assurance across all 3PL operations, ensuring compliance with applicable regulatory, client, and quality requirements. The role leads the Quality Management System, maintains inspection readiness, provides quality oversight of cleanroom sampling and dispensing and environmental monitoring, and drives continuous improvement through investigation, trend analysis, and performance reporting. The manager serves as the primary quality contact for commercial clients and leads, coaches, and develops a team of QA professionals, including the Sampling and Dispensing Supervisor.

The position is performed primarily in an office, with regular time in warehouse and cleanroom areas as needed. Warehouse areas may involve temperature variations, noise, and material-handling equipment. The role may require travel up to 15%, cleanroom gowning and PPE, frequent walking and standing, and occasional lifting of up to 50 pounds. Candidates must pass preliminary employment requirements, including a background check and drug screen, and have a valid driver’s license.

Requirements

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related field; equivalent experience may be considered.
• At least 5 years of quality experience in the pharmaceutical, medical device, or another FDA-regulated industry.
• At least 3 years of supervisory experience.
• Working knowledge of state and federal laws and regulations governing warehousing and distribution of pharmaceuticals and medical devices, including FDA, DEA, PDMA, and DSCSA, and ability to interpret and apply them.
• Excellent verbal and written communication and presentation skills.
• Strong analytical skills, including investigation, root-cause analysis, and trending and presentation of quality metrics.
• Sound critical thinking and attention to detail.
• Strong organization and time management skills, with ability to prioritize in a fast-paced environment.
• Ability to learn and use quality and warehouse management systems, including eQMS, LIMS, Tecsys Elite, and WebCTRL; training is provided.
• Proficiency in Microsoft Outlook, Excel, Word, and PowerPoint.
• Must successfully pass preliminary employment requirements, such as a background check and drug screen.
• Must be able to travel up to 15%.
• Must have a valid driver’s license.
• Physical ability to perform light to medium work, including frequent walking and standing, periods of sitting, occasional lifting of up to 50 pounds, and gowning and wearing PPE for cleanroom entry.
• Ability to analyze data, manage multiple priorities, make timely decisions, and communicate effectively under deadlines.
• Ability to read documents, screens, and labels and visually inspect materials and records.

Nice To Haves

• Experience in 3PL, warehouse, or distribution quality operations.
• Experience with cleanroom operations, sampling and dispensing, and environmental monitoring.
• Experience hosting regulatory inspections and client audits.
• ASQ certification, such as CQA, CQM/OE, or CPGP, and/or ISO auditor certification.

Responsibilities

• Ensure compliance with FDA regulations, cGMP, DEA, DSCSA, applicable state licensing requirements, and client-specific quality requirements across 3PL operations.
• Maintain inspection readiness for internal, client, and regulatory audits; lead or support inspections and audits and ensure timely, complete responses and follow-through on commitments.
• Support the internal audit (self-inspection) program and supplier/vendor qualification activities.
• Oversee and continuously improve QMS processes, including deviations and nonconformances, CAPA and effectiveness checks, change control, document control and record retention, GMP training and personnel qualification, product complaints, returns, recalls, and temperature excursions.
• Ensure investigations are thorough, root causes are identified, and corrective actions are effective and sustainable.
• Ensure data integrity and electronic record compliance in eQMS, LIMS, and other GxP systems.
• Exercise quality authority to quarantine, hold, and release product according to approved procedures.
• Provide quality oversight of cleanroom sampling and dispensing, including adherence to SOPs, cGMP, and aseptic practices; timely review of records, labeling, chain of custody, and line clearance; and investigation and resolution of related deviations.
• Oversee the cleanroom environmental monitoring program, including data review and trending, investigation and CAPA for excursions, and maintenance of qualification, cleaning/disinfection, and monitoring requirements.
• Lead initiatives to improve quality performance, reduce variation and deviations, and increase Right-First-Time execution and operational efficiency.
• Analyze quality trends, metrics, and KPIs to identify systemic issues and support data-based decisions; report quality performance and improvement actions at management review.
• Serve as primary quality contact for commercial clients; communicate and partner effectively, address concerns and quality events urgently and transparently, meet client notification requirements, and support quality agreement development, maintenance, and compliance.
• Lead, coach, and develop QA professionals, including the Sampling and Dispensing Supervisor; establish roles, responsibilities, and expectations; and participate in hiring, performance reviews, and development planning.
• Promote accountability, ownership, and quality excellence across the organization.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager