Job Description

Reference # : 18-03162Title : Instrument Compliance Specialist
Location : New Brunswick, NJ
Position Type : Contract
Experience Level : Start Date / End Date : 04/04/2018 / 10/03/2018
Assignment Detail
Industry:Biotech/PharmaJob Category:QA / QC
Description
Instrument Compliance Specialist

Eclaro is looking for an Instrument Compliance Specialist for an opportunity with our client in New Brunswick, NJ
Job Title: Instrument Compliance Specialist
Location: One Squibb Drive New Brunswick, NJ 08903
Schedule: 40 hours/week

Responsibilities:
  • Responsible for assisting analytical instrument owners, to navigate through the requirements of the GMP instrument program from qualification to decommissioning.
  • This includes, but is not limited to qualification, vendor protocol preapproval, periodic calibration, performance verification, preventive maintenance, change control, decommissioning and documentation archival.
  • Responsibilities include collaboration with the quality unit to insure completeness and accuracy of submitted documentation, as well as addressing/resolving compliance concerns to GMP regulatory standards.
  • Collaborating with external contract service providers to ensure the requirements of the GMP instrument programs are met
  • Provide support to the Analytical Strategy & Operations (ASO) management team in internal and external audit inspections.
  • In addition, the candidate will be responsible for continuing to drive the transition from instrument paper logbooks to an electronic instrument logbook.

Qualifications
  • The qualified individual must have a Bachelor of Science or related field.
  • 2-5 years of experience preferred within a regulated GMP environment, but not required.
  • Experience using instrumentation for various analytical techniques with a focus on qualification.
  • Candidate must be detail oriented, well organized, and an excellent communicator with exceptional technical writing skills.
  • Capable of working both independently as well as with the team driving projects to completion with minimal oversight.
  • Knowledge of laboratory GMP principles (21CFR Part 210/Part211) and Good Documentation Practices (GDP) is required.
If interested, you may contact:
Froilyn Jane Bautista

Froilyn.Bautista@eclaro.com
(201) 285-8622

ECLARO is a company that delivers talent. We provide fully customizable, comprehensive talent acquisition and management of seasoned professionals through a number of business models, including: Consulting, Professional Hire, Global Integrated Delivery™ and Managed Services. ECLARO recruits and manages a staff of highly skilled individuals in an array of specialized disciplines. This approach enables our clients to leverage new opportunities, respond to increased and changing demands and increase their profitability. Please visit www.eclaroIT.com to see why the Right People are The Answer™.

Specialties: Customized solutions for Human Capital and Talent Acquisition, Permanent placement and retained search, Recruiting, Staff Augmentation, Contract Labor, Managed Services, RPO, MSP, VMS, IT solutions, management and support, offshore business process outsourcing.

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Website: http://www.eclaro.com
Industry: Staffing and Recruiting
Type: Privately Held
Company Size: 501-1000 employees
Founded: 1999

Application Instructions

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