QA Specialist

** 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.
** If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

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

*
* Schedule:

** M-F, 1st shift

** Location** :
Erlanger, KY

** 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

** QUALIFICATIONS*
* ** Education*
* + Bachelor's degree in Business Administration, Chemistry, Engineering, or a related discipline.

+ Equivalent experience may be considered in lieu of a degree.

** Experience*
* + 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.

** Regulatory Knowledge*
* + 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)

** Skills & Competencies*
* + 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

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