Senior Specialist Quality Assurance Hybrid role (Onsite + Remote)
- Posted: over a month ago
Qualifications:Education: • 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. Preferred - statistical knowledge is helpful • Experience with statistical platforms such as JMP and Spotfire, SAS, SDMS. Nice to have: Veeva Vault Quality Docs. Personality: – You have impeccable attention to detail and a quality mindset! You are a fast-learner; a team-player! Accountable and adaptable, you are willing and able to jump in and help when and wherever needed! You are collaborative and open to new ideas! *Note*: Position: 2 available. The main goal is to help us complete implementation and migration of all our studies in the new LIMS system. Hybrid role (Onsite + Remote), need to be flexible for onsite work at least 3 days/week at west point, PA. Shift flexibility (7a-4p/8a-5p/9a-6p). This is not a lab based role for sample testing but will require sample handling, GMP documentation, and sample storage management. This role requires the understanding of stability study, techniques used for sample testing. Exposure and interactions globally and cross functionally.
Responsibilities: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 Merck 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: 1. Effectively utilizes applicable computer applications, including Laboratory Information Management System (LIMS), Microsoft Word, Excel, Access and statistical platforms (i.e. JMP and Spotfire.) 2. 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. 3. 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. 4. Entering of stability testing results within LIMS system 5. 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. 6. Prepares samples for shipment to external testing sites and submits necessary paperwork to arrange for shipment. 7. Prepares paperwork and labels for dispensing activities performed by the stability technician. 8. Prepares data tables using MS Word to communicate testing results to customers, as instructed by the stability analyst. 9. Supports the Stability Chamber Coordinator with facility and chamber requests (e.g. work orders, shop floor inspections, chamber review). 10. Incumbent must complete technical assignments independently once specific objectives have been defined.
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Pyramid Consulting, Inc. provides Staffing and Technology Solution services to Fortune 500 and 1000 companies across the USA and Canada.
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AddressWest Point, PA
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