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Quality Assurance Specialist I

LifeScience LogisticsAuburndale, Florida, United StatesOnsite
  • Provide support during regulatory FDA, DEA, State inspections and customer audits.
  • Plan and present Quality System information to internal and external groups
  • Initiate, review, and approve Change Controls, Recalls, Deviation for nonconformances, & Reactive Maintenance
  • Work to maintain Quality Systems policies and procedures to ensure regulatory compliance
  • Be a part of the internal audit team and assist in external audits
  • Release “quarantined” product upon receipt of documentation from Client and use Hold and Release process, take part in Recall
  • Review/approve product-specific paperwork particular to Client guidelines, Deviations and CAPAs
  • Assist in Operations and Facilities team in determining root cause of discrepancies and help develop corrective actions and verification activities
  • Revise SOPs and WIs for process enhancement
  • Perform Gemba walk applies six sigma concepts such as 5S’s
  • Participate in cross-functional initiatives for a 3PL environment
  • Strong leadership skills and logistics (3PL) knowledge
  • Able to professionally communicate with customers/clients
  • Assist in returns and damages process
  • Perform record reviews to ensure compliance with all applicable procedures and regulations
  • Take part on ISM (Inventory System Management) after hours rotation program
  • Assist in validation projects
  • Being able to be on call for WebCTRL temperature monitoring on a rotation program
  • Assist in generating and reviewing temperature monthly reports in a timely manner
  • Other duties as assigned

Life at LifeScience Logistics

Life Science Logistics is committed to offering the highest quality, flexibility, and compliance in healthcare supply chain solutions. We offer a wide range of customizable solutions, including warehousing, distribution, order-to-cash management, quality assurance and regulatory support. Our highly secure, cGMP-compliant, facilities allow our clients to distribute frozen, refrigerated and controlled room temperature products, while outsourcing as much of the process as they desire. Life Science Logistics is Board of Pharmacy-licensed, VAWD-accredited, cGMP-compliant and FDA-licensed. Our can-do attitude sets us apart from our competition, and we pride ourselves on bringing the best technology, quality and intellectual capital to our clients.
Thrive Here & What We Value- Adherence to Strict Appearance Guidelines- PPE Provided for Employee Safety- Hazardous Conditions May Exist in the Workplace- Equipment Operated: Forklift, Floor Scrubber, Pallet Jacks, RF Scan Guns/Scanners- Emphasis on Teamwork and Collaboration- Continuous Improvement and Process Optimization- Personal Growth and Development through Training Opportunities- Safety and Security as Top Priority- Positive Work Environment with Open Communication Channels- Flexible Schedule (No Weekends)- Ability to Prioritize Tasks and Act with Urgency- Good Research Skills, Organized, Knowledgeable about Data Privacy Regulations- Equal Opportunity Employer with Affirmative Action Policies- Importance of Employee Safety through PPE Provision- Maintaining a Sanitary Warehouse Environment
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