Quality Assurance Specialist

Kelly® Science & Clinical is seeking a Quality Assurance Specialist for a direct hire position with a national pharmaceutical leader at their site in Erlanger, KY.

Compensation: $65,000-$70,000/yr

Schedule: M-F, 1st shift

• 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.

• 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
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• 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
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• Proficient with QMS/eQMS systems and warehouse documentation.