Quality Assurance Specialist I chez LS Logistics

Responsibilities

•  Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports
•  Assess revalidation requirements and prepare recommendations and plans for activities
• Assist computer system validation efforts
•  Support the transfer of new equipment and processes
• Develop and execute validation protocol and final report of temperature controlled environments
•  Provide support during regulatory inspections and client audits
•  Implement quality system improvements when gaps are identified through audits and departmental reviews
• Perform annual environmental control reviews and prepare summary reports
• Prepare and submit various temperature reports on a monthly basis
• Author and or revise Standard Operating Procedures, Work Instructions, and training modules with Functional Owners in alignment to control critical systems and ensure conformance to client-specific requirements.
• Notify Facilities Management, Operations, and Quality leaderships of any unusual temperature trends
• React and respond to temperature system alarms and alerts
• Maintain files of all validations, revalidations, and calibrations
• Interact with state and federal agencies, clients, and corporate quality group
• Plan and present Quality System information to internal and external groups
• Work with Quality Systems, policies, procedures, and all levels of facility personnel to achieve company quality standards and to ensure regulatory compliance
• Help guide Operations team in determining root cause of discrepancies and assist in developing corrective/preventative action plans and verification activities
• Maintain communication with Quality group supplying reports as requested
• Complete documents for change management, deviation/non-conformance, and CAPA
• Rotate to be on called for temperature monitoring
• Other duties as assigned

Qualifications and Job Specifications

• Minimum Bachelor of Science (BS) degree in Engineering, Science, or related field (preferred)
• Minimum of 2 years experience in validation (temperature mapping and computers) and calibration (preferred)
• Demonstration of the following:
  • Take ownership
  • Effective time management skills
  • Excellent verbal and written communication skills
  • Strong presentation skills
  • Attention to details and organize
  • Critical thinking
  • Interest in working in a fast-paced environment

Technical Expertise

• Deftly navigate through Quality and Warehouse Management Systems with training – QMS CQ, Tecsys Elite, WEBCTRL (preferred)
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint, PDF
• Knowledge of IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Performance Qualification) validation principles and practices that can be applied to a wide variety of equipment and process validations
• Experience in temperature monitoring of controlled environments
• Conversant with cGMPs, Quality Systems Change Controls, Deviations/Non-Conformances, and CAPAs per 21 CFR 210/211, 820 and Part 11
• Verifiable aptitude of FDA regulations (preferred)
• Intermediate public speaking and presentation skills

Additional Employment Requirements

• Must be able to successfully pass all preliminary employment requirements (i.e. background check and drug screen)
• Must be able to travel up to 10%
• Must have a valid driver’s license

Physical/Mental/Visual Demands

• Work is light to medium in nature with frequent walking to perform assigned tasks
• Must not be afraid of heights
• Ability to handle multiple priorities & solve inquiries/issues expeditiously and efficiently
• Must be able to read at a distance, close to the eyes, and at arm’s length with or without correction

Working Conditions

• Activities occur within a typical office environment and warehouse setting
• 25% of the time will be spent in a warehouse setting during validation activities

Equipment Operated

• Equipment: Laptop computer, cell phone, copier, and desk phone
• Systems: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software) and ComplianceQuest (Quality Management Software)

* NO AGENCIES PLEASE *