Job Number: 21139167
QUALITY ASSURANCE SPECIALIST
WEST POINT, PA
- 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.
- 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
ALPHA'S REQUIREMENT #22-02157
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE