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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

Commissioning/Qualification Specialist / Specific Commissioning and Validation support

Job Description

  • Location: Devens, MA
  • Type: Contract
  • Job #73176

Our client, a leading pharmaceutical company, is hiring a Commissioning/Qualification/Specific Commissioning and Validation Support on a contract basis.

Work Location

Devens, MA/Hybrid

Summary

– 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 instruments 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:

 

– Bachelors 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

 

 

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