$50/hr – $51.04/hr
Description: 100% onsite with some flexibility
Work Schedule: Mon-Fri(normal business hours)

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/Client)
– 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 GMP experience
– Microsoft Office Applications, preferred.
– Computer system validation experience, preferred
– Equipment validation experience is a plus

Additional Job Requirements: None