JOB DESCRIPTION:
Responsibilities will include (but not limited to):
- Manage the entire lifecycle of QC laboratory instruments from procurement to qualification to decommissioning, ensuring all activities are in compliance with applicable policies/regulations.
- Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary reports
- Author/execute computer system validation scripts using an electronic validation database (ALM), or paper-based
- Own change controls specific to the qualification of QC instruments and its associated software
- Update the asset management database to reflect new assets, calibrations, preventative maintenances
- Author instrument operational SOPs as needed
- Coordinate/interface/host vendors on site
- Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/PAs)
- Acts as the liaison between Digital Plant (IT) and lab departments
- Execute periodic assessments/decommissioning, as needed
Qualifications and Experience Required:
- Required Bachelor s degree or Master s degree in Engineering, Chemistry, Biology, or in a related, scientific/computer-based field.
- Minimum of 2 4+ years experience in the biopharmaceutical industry or equivalent combination of education and validation/lab experience will be considered.
- Quality management system experience including: document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
- Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
- Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
- Demonstrated success in cross functional influencing, strong communication, and collaboration skills
- Must have experience
- Microsoft Office Applications, preferred.
- Computer system validation experience, preferred
- Equipment validation experience is a plus
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