Job Description

Reference # : 17-12063Title : Pharmaceutical Validation Specialist (Non-IT)
Location : Devens, MA
Experience Level : Start Date / End Date : 12/12/2017 / 06/11/2018
Assignment Detail
Industry:Biotech/PharmaJob Category:Scientific / Clinical
Description
Validation Specialist


Work for a global healthcare leader. Eclaro is looking for a Validation Specialist for our client in Devens, MA.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

RESPONSIBILITIES:

Perform the QA review/approval of analytical documentation:
  • Analytical method validation protocols and reports for in-process and release/stability testing
  • Analytical method procedures and associated change controls
  • Method technical transfer protocols and reports
  • Reference Standard and Critical Reagent qualification protocols and reports
  • Certificates of Analysis for reference materials and critical reagents
  • Standard Operating Procedures and other guidance documents
Collaborate with clinical or commercial analytical functions to determine the appropriate resolutions or CAPAs for protocol deviations/exceptional conditions related to method validations, technical transfers or reference standard/critical reagent qualifications.

Collaborate with manufacturing support functions to develop the methods and acceptance criteria for the development of raw material specifications in preparation for Process Performance Qualification activities

QUALIFICATIONS:

Skill Set Desired:
  • Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials.
  • Experience with the review and approval of method validation protocols and reports.
  • Experience collaborating with technical teams to develop validation strategies that are compliant to regulatory guidance and Client policies.
  • Experience collaborating with technical subject matter experts to resolve validation protocol or report compliance gaps and indicate if technical gaps are present with the overall validation strategy.
  • Experience collaborating with technical subject matter experts to resolve protocol deviations and investigations.


If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro


Interested in applying?
Send your resume to Cheryl.Buot@eclaro.com now.
www.linkedin.com/in/cheryl-buot-56ba4836


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.

Application Instructions

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