Job Description

WANT TO BRING YOUR EXPERIENCE IN THE MEDICAL DEVICE/PHARMACEUTICAL ENVIRONMENT AND MAKE A BIG DIFFERENCE?

DO YOU WANT TO BRING YOUR PROJECT MINDSET TO AN ORGANIZATION WITH OUTSTANDING CULTURE?

DO YOU FEEL COMFORTABLE INTERACTING WITH ALL LEVELS IN AN ORGANIZATION?

BRING YOUR TIME MANAGEMENT EXPERIENCE TO WORK WITH US!

The Validation Specialist is responsible for maintaining a robust validation system which ensures products and services are reliable, safe, and effective.

QUALIFICATIONS:

• Minimum Bachelor of Science (BS) degree in Engineering, Science, or related field (preferred)
• MINIMUM OF 2 - 3 YEAR’S EXPERIENCE IN VALIDATION (TEMPERATURE MAPPING AND COMPUTERS) AND CALIBRATION

TECHNICAL EXPERTISE:

• Navigate through Quality and Warehouse Management Systems with training – MQ1, Tecsys Elite, WEBCTRL (preferred)
• Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint, PDF
• Knowledge of IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Production 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 and CAPAs per 21 CFR 210/211, 820 and Part 11
• Verifiable aptitude of FDA regulations (preferred)

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 20%
• Must have a valid driver’s license

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 such activities
• Lead data integrity initiatives, as assigned
• Assist computer system validation efforts
• Support the transfer of new equipment and processes
• Lead, develop and execute validation protocol and final report of temperature controlled environments
• Provide support during regulatory inspections and client audits
• Identify and implement quality system improvements when gaps are identified through audits and departmental reviews
• Prepare and submit various temperature reports
• Notify Facilities Management, Operations Managers, and CQCU of any unusual trends
• React and respond to temperature system alarms and alerts
• Maintain files of all validations and calibrations
• Interact with state and federal agencies, clients, and corporate quality group
• Work with Quality Systems, policies and 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 help develop corrective actions and verification activities
• Assist with vendor qualification and due diligence
• Maintain communication with Corporate Quality group supplying reports as requested
• Complete documents for change management, deviation/non-conformance, CAPA, and inventory status modifications

WORKING CONDITIONS

• Activities occur within a typical office environment and warehouse setting
• 15% of time will be spent in a warehouse setting

EQUIPMENT OPERATED

EQUIPMENT: Laptop computer, cell phone, copier, and desk phone

SYSTEMS: Outlook, Excel, Word, PowerPoint, WebCTRL (Temperature Monitoring Software), TECSYS (WMS – Warehouse Management System) and MQ1 (Quality Management Software)

LifeScience Logistics is an equal opportunity employer that takes affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, national origin, protected veteran status, disability, sexual orientation or gender identity. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Company Description

Do you always find a way? LifeScience Logistics offers a variety of careers in the healthcare supply chain. We are continuously seeking qualified candidates who believe in the power of “yes.” We offer challenging career growth possibilities in an environment that embraces innovation, vision, and unwavering dedication.