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Quality Assurance for Biologics Drug and Drug Products
Ref No.: 17-01333
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 10/16/2017 to 04/15/2018
QUALITY ASSURANCE FOR BIOLOGICS DRUG AND DRUG PRODUCTS
DEVENS, MA

Project Description:
Need someone who can clear and start on the 16th. Perform the QA review/approval of biologics analytical documentation, including, but not limited to:
  • 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.

Required Skills:
  • 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
  • Excellent communication skills.
  • Knowledge of process development documentation.


This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Karen: karen@alphaconsulting.com

ALPHA'S REQUIREMENT #17-01333
W2 ONLY