Position SummaryThe Supervisor, Quality Assurance role is responsible for day-to-day quality oversight of warehouse and distribution operations at an FDA-registered API distribution facility. This role ensures that all receiving, storage, handling, sampling, labeling, release, and distribution activities are performed in compliance with FDA cGMP (21 CFR Parts 210/211), applicable GDP principles, and internal quality procedures. The position serves as the primary quality presence on the warehouse floor, partnering closely with Operations, Supply Chain, and Logistics to ensure compliant execution while supporting efficient, uninterrupted API distribution.
Key Responsibilities- Provide routine on-site quality oversight of API warehouse operations, including receiving and quarantine, storage and segregation, environmental and temperature-controlled storage, order picking, packing, and shipment, returns and reverse logistics.
- Ensure warehouse activities comply with approved SOPs, GDP requirements, and regulatory expectations.
- Oversee and manage receiving records, Certificates of Analysis (CoAs), lot traceability records, and distribution documentation.
- Oversee and manage quality release activities for APIs prior to distribution, as applicable to LGM Pharma's regulatory model.
- Ensure full lot traceability from receipt through shipment.
- Author/Lead investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints
- Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs.
- Oversee and manage personnel performance of root cause analysis and verify effectiveness of corrective actions.
- Oversee warehouse environmental controls, including:
- Temperature and humidity monitoring
- Alarm response and excursion management
- Mapping, qualification, and requalification activities
- Manage/Lead qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems.
- Manage and approve operational change controls impacting warehouse activities, layout, equipment, or processes and ensure changes are implemented in a controlled and compliant manner.
- Author/Lead risk assessment activities related to storage, handling, and distribution activities.
- Collaborate with Quality Operations Program to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements.
- Support onboarding, retraining, and periodic GMP refreshers.
- Provide real-time quality guidance to quality operations staff.
- Serve as the quality operations management representative during FDA inspections and audits
- Ensure warehouse documentation and practices are always inspection ready.
- Lead/Support responses to audit findings and FDA Form 483 observations related to warehouse operations.
- Partner closely with Warehouse Operations, Supply Chain, Logistics, Supplier Quality, and Quality Systems.
- Provide quality input into process improvements, capacity expansion, and business continuity planning.
- Support vendor oversight related to 3PLs, couriers, and transportation providers.
- Develop, track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc.
- Manage/drive continuous improvement initiatives to enhance compliance, efficiency, and reliability.
- Other duties as assigned
Required Qualifications- Bachelor's degree in Business Administration, Chemistry, Engineering, or a related discipline or equivalent experience may be considered.
- 6-10 years of quality experience in the pharmaceutical industry.
- 3+ years supporting warehouse, distribution, or GMP operations.
- Experience with API distribution, GMP/pharmaceutical warehousing, or 3PL oversight required.
- Hands-on experience with GDP and warehouse quality operations required.
- Strong working knowledge of:
- 21 CFR Parts 210 & 211, 21 CFR Part 11, ICH Q7, Q9, Q10
- GDP principles for pharmaceutical distribution
- FDA inspection expectations for API distribution facilities
- Data integrity and documentation practices
- DEA requirements for controlled substances (if applicable)
- Ability to assess operational risk and make sound quality decisions.
- Strong investigation, root cause analysis, and CAPA skills.
- Excellent communication skills for working with operations teams.
- Ability to work effectively in a hands-on, GMP warehouse environment.
- Proficient with QMS/eQMS systems and warehouse documentation
