Quality Assurance Specialist

West Point, PA

Posted: 07/15/2022 Job Number: 21139167

Job Description

Hybrid Role.

Project Description:
  • The Global Vaccine Stability group in West Point is responsible for running studies to test the stability or shelf life of products.
  • In this role, you will be teaming up with Client staff analysts to receive, store, label, and ship samples to support stability studies.
  • You will also author stability testing protocols, as well as review and approve test results and escalate any atypical results.
  • This is not a laboratory testing position, but you will interface with the testing labs and review the data that they generate from testing the stability studies managed by the vaccine stability group.
  • Although the person maybe helping with all the below actions, the main goal is to help us complete implementation and migration of all our studies in the new LIMS system.
  • Here is a breakdown of role responsibilities:
    • Effectively utilizes applicable computer applications, including Laboratory Information Management System (LIMS), Microsoft Word, Excel, Access, and statistical platforms (i.E., JMP and Spotfire.).
    • Develops clear, accurate documentation from associated activities and with supervision, prepares status reports and presentations for the Stability Group.
    • The projects assigned are technical in nature and require a working knowledge of testing methods and GMP Compliance.
    • Provides 100% second person review support for team members stability documents to source documents to ensure accuracy, compliance, integrity, completeness, and traceability of each document.
    • Entering of stability testing results within LIMS system.
    • Assists in the submission of samples for retests as instructed by the stability analyst/lab personnel.
    • Provides additional samples at the request of testing labs after approval by the stability analyst.
    • Determines whether sufficient inventory remains to complete the scheduled testing (as defined in the protocol) prior to distributing any additional samples.
    • Discusses with supervisor any potential shortage and appropriate actions.
    • Prepares samples for shipment to external testing sites and submits necessary paperwork to arrange for shipment.
    • Prepares paperwork and labels for dispensing activities performed by the stability technician.
    • Prepares data tables using MS Word to communicate testing results to customers, as instructed by the stability analyst.
    • Supports the Stability Chamber Coordinator with facility and chamber requests (e.G., work orders, shop floor inspections, chamber review).
    • Incumbent must complete technical assignments independently once specific objectives have been defined.

Required Skills:
  • BS /MS - Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent).
  • 2-5 years' experience in the Pharmaceutical Industry/Laboratory/quality control.
  • Should have experience with GMP's.
  • Previous experience as a Quality Assurance professional.
  • Working knowledge of Microsoft Excel & Macros.
  • Experience with Midas and LIMS & GLIMS.
  • Experience with statistical platforms such as JMP and Spotfire, SAS, SDMS.
  • Veeva Vault Quality Docs.
  • Impeccable attention to detail and a quality mindset!
  • Fast-learner; a team-player.
  • Accountable and adaptable.
  • Willing and able to jump in and help when and wherever needed.
  • Collaborative and open to new ideas.

This 4+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Rose: Rose@alphaconsulting.Com


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Rose Minchello

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