Commissioning/qualification Specialist Job In Devens, Massachusetts, Axelon Services Corporation

Published 2022-09-23
Expires 2022-10-23
ID #1181639547
Commissioning/qualification Specialist Job In Devens, Massachusetts, Axelon Services Corporation
United States, Massachusetts, Devens,
Published September 23, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Commissioning/qualification specialist

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Job Description: Responsibilities will include (but not limited to):

- 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

Qualifications and Experience Required:

- 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

Additional Job Requirements:


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