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(this posting is now closed/inactive)
Raleigh, NC 27606 United States
617 Hutton St, Suite 101
60,000 - 70,000 plus benefits
Research and Development
Local candidates only – will not cover relocation
Must be legally able to work in the USA without requiring sponsorship.
The Validation Specialist will support the Qualification, Validation, Calibration, Preventive Maintenance, Requalification, Revalidation, Recalibration, and Decommissioning programs for lab instruments, equipment and software.
EXPERIENCE STRONGLY DESIRED IN:
Pharma Manufacturing equipment qualification
Quality Assurance: Review and approval of equipment qualification documents
Pharma Analytical Laboratory equipment knowledge
DUTIES & ESSENTIAL JOB FUNCTIONS
Write, review and/or approve validation master plan, SOPs, validation protocols and reports, and coordinate with external vendor(s).
Review calibration certificates, equipment or room certifications, and raw data/reports from periodic calibration activities and identify any issues or concerns.
Maintain instrument/equipment inventory and calibration schedule.
Write, review and/or approve the investigation and CAPA of out of tolerance (OOT) calibration events.
Participate in decision meetings related to change controls, validation activities, selection of new equipment/systems, or determination of calibration requirements.
Support FMEA and risk analysis for validation activities.
Perform other validation duties as assigned by manager.
OTHER FUNCTIONS AND RESPONSIBILITIES
Maintain Quality Assurance logbooks for document change control, part and lot numbers, certificates of analyses, technical reports and test methods, investigation and variance numbering logs.
Issue and archive notebooks/logbooks.
Filing of data, calibration reports, and training records.
Manufacturing support activities will include quarantine and release of GMP materials, performance of line clearances, and maintenance of clinical trial material inventory logs.
Perform internal audits of the Analytical Laboratories, Manufacturing, and Quality Assurance systems.
Bachelor’s degree in Science, Engineering or related field with 3+ years or MS with 1+ years of experience working in a FDA regulated manufacturing or laboratory environment.
Knowledge of 21 CFR Parts 11, 210, and 211.
Excellent oral and written communication skill and working in a team environment is essential.
Minimum of 2 years Validation experience preferred.
Knowledge of Good Automated Manufacturing Practice (GAMP).
Experience with Inhalation and Dermatological equipment.
North Carolina Biotechnology Center