QUALITY ASSURANCE SPECIALIST

LGM Pharma, LLC•Erlanger, KY

2d•Onsite

About The Position

Key Responsibilities Execute routine on-site activities relevant to quality 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. Revise and/or author SOPs, forms, and controlled documents Execute receiving records, Certificates of Analysis (CoAs), lot traceability records, and distribution documentation. Execute quality release activities for APIs prior to distribution, as applicable to LGM Pharma’s regulatory model. Assist with investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints, and other discrepancies as assigned Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs. Monitor warehouse environmental controls, including: Temperature and humidity monitoring Alarm response and excursion management Mapping, qualification, and requalification activities Participate in the qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems. Assist with change controls impacting warehouse activities, layout, equipment, or processes and ensure changes are implemented in a controlled and compliant manner. Represent QA in risk assessment activities related to storage, handling, and distribution activities. Collaborate with quality colleagues to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements. Support onboarding, retraining, and periodic GMP refreshers. Execute backroom activities during FDA inspections and audits Ensure warehouse documentation and practices are always inspection-ready. 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. Support vendor oversight related to 3PLs, couriers, and transportation providers. Track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc. Execute continuous improvement initiatives to enhance compliance, efficiency, and reliability. Escalate quality risks and compliance issues to QA management Other duties as assigned

Requirements

Bachelor’s degree in Business Administration, Chemistry, Engineering, or a related discipline.
Equivalent experience may be considered in lieu of a degree.
2-4 years of quality experience in the pharmaceutical industry.
2+ 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)
Strong understanding of warehouse operations and quality oversight.
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

Responsibilities

Execute routine on-site activities relevant to quality 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.
Revise and/or author SOPs, forms, and controlled documents
Execute receiving records, Certificates of Analysis (CoAs), lot traceability records, and distribution documentation.
Execute quality release activities for APIs prior to distribution, as applicable to LGM Pharma’s regulatory model.
Assist with investigations related to warehouse deviations and nonconformances, temperature excursions, shipping errors or damage, inventory discrepancies, product quality complaints, product handling complaints, and other discrepancies as assigned
Collaborate with SCD Quality Program Management to ensure timely initiation, investigation, and closure of deviations and CAPAs.
Monitor warehouse environmental controls, including: Temperature and humidity monitoring Alarm response and excursion management Mapping, qualification, and requalification activities
Participate in the qualification and maintenance of (not all inclusive) warehouse storage areas, temperature-controlled equipment, data loggers, equipment, and monitoring systems.
Assist with change controls impacting warehouse activities, layout, equipment, or processes and ensure changes are implemented in a controlled and compliant manner.
Represent QA in risk assessment activities related to storage, handling, and distribution activities.
Collaborate with quality colleagues to ensure warehouse personnel are GMP/GDP trained, qualified, and compliant with role-based training requirements.
Support onboarding, retraining, and periodic GMP refreshers.
Execute backroom activities during FDA inspections and audits
Ensure warehouse documentation and practices are always inspection-ready.
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.
Support vendor oversight related to 3PLs, couriers, and transportation providers.
Track and trend quality operations metrics related to warehouse operations, such as: Temperature excursions, deviation rates, shipping errors, documentation timeliness, etc.
Execute continuous improvement initiatives to enhance compliance, efficiency, and reliability.
Escalate quality risks and compliance issues to QA management
Other duties as assigned