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)
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.
