Job Description

Reference # : 18-03799Title : Validation Specialist (Pharmaceutical - Analytical Methods Validation)
Location : Devens, MA
Position Type : Contract
Experience Level : Start Date / End Date : 04/24/2018 / 10/23/2018
Assignment Detail
Industry:Biotech/PharmaJob Category:QA / QC
Description
Validation Specialist


Work for a global healthcare leader. Eclaro is looking for a Validation Specialist for our client located 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!

JOB DESCRIPTION:
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.
QUALIFICATIONS:
  • BS/BA in a life science field.
  • Minimum of 8 years of experience in a Quality Assurance organization responsible for the review of documents pertaining to release and stability analytical test methods for biologics drug substances and drug products.
  • Broad compliance knowledge (cGMP, ICH, FDA/EU guidance, WHO) as it applies to the evaluation of technical documents for analytical methods and reference materials
  • Knowledge of process development documentation.

If interested, you may send your resume to:
Cheryl.Buot@eclaro.com

https://www.linkedin.com/in/cheryl-buot-56ba4836


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
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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