Vacancy expired!
LAB INSTRUMENT QUALIFICATION SUPPORT DEVENS, MA Hybrid Role. Required Skills:
- Bachelor's degree in relevant scientific or computer area with 7 - 10 years' experience in the biopharmaceutical industry or MS degree with 6+ years' experience or equivalent combination of education and experience.
- Minimum 6 years' experience in a role either (a) QC instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software.
- Demonstrated expertise in large projects, prioritizing workload with minimal supervision.
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment.
- Self-directed with a high degree of professional integrity, organization, and attention to detail.
- Strong interpersonal, oral, and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
- Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
- Ability to travel when required.
- Participate as part of a cross functional global project to qualify QC instruments and associated software.
- Create, execute, and review network-led QC instrument/software qualification documents in support of global QC projects.
- Support the implementation of a standardized global qualification for QC instrumentation and associated software across multiple Client QC sites.
- Author qualification related deviations, identifying root causes and robust CAPAs.
- Author qualification related change controls and validation plans.
- Update Client procedures and documents to implement data integrity controls arising from instrument qualification programs.
- Serve as liaison with lab-IT teams to harmonize QC instrument's software configurations where applicable.
- Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
- Provide updates on qualification status, project timelines, and escalate challenges as required.
- Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team.
- Support general QC asset management.
- Coordinate/interface with vendors for servicing/maintenance/upgrades.
- Execute periodic assessments/decommissioning as needed.
Vacancy expired!