Job Number: 20951931
LAB INSTRUMENT QUALIFICATION SUPPORT
- Bachelor's degree in relevant scientific or computer area with 3 - 5 years' experience in the biopharmaceutical industry or MS degree with 2 years' experience or equivalent combination of education and experience.
- Minimum 2 years' experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software.
- Demonstrated expertise in large projects.
- Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritize workload with minimum supervision as part of supporting multiple complex projects.
- 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 such as:
- Network QC Instrumentation Standardization and Windows 10 upgrades.
- Deployment of Enterprise Empower3 FR5 to QC sites including requalification of associated QC instruments.
- Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five Client QC sites.
- Implement validation strategies for QC instrumentation and associated software, across Client QC Laboratories.
- 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.
This 12+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Maureen: maureen@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02017
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE