LIMS Stability Coordinator

  • Temporary/Contract Positions
  • Exton, PA

Title: Stability Coordinator

Industry: Pharmaceutical

Location: Exton, PA – On site required once Federal Mandates are lifted

Contract Term: 1  year

Please note: Qualified candidates will have:

  • Two plus years professional experience in LabVantage LIMS, LabWare LIMS, Quality Systems, IT Strategy, and BusinessObjects
  • Past roles include as a LIMS lead, LIMS analyst, process analyst, master data builder, trainer, or developer
  • Experience as a Technical Writer in the Pharmaceutical arena
  • BS in chemistry, biology or a related scientific discipline
  • 1-3 years scientific background

 

Description:

 

  • Represent Analytical Outsourcing (AOS) as the LabVantage SME and responsible for:

o Being a liaison between AOS and IT

o Training LabVantage Stability Module

o Entering and managing stability protocols

o Generating reports and tech memos for stability extensional use for product batches and standards

o Entering and tracking data for stability of product batches.

o Writing stability related sections in dossiers

o Managing shipment of stability samples as needed

o Technical writing including preparation/formatting of documents of regulatory submissions, technical memos, etc.

o Management of budgets and shipping requests for analytical studies

o Coordination of document review and approval processes and archiving

 

Desired qualifications include:

 

  • Two plus years professional experience in LabVantage LIMS, LabWare LIMS, Quality Systems, IT Strategy, and BusinessObjects
  • Past roles include as a LIMS lead, LIMS analyst, process analyst, master data builder, trainer, or developer
  • Experience as a Technical Writer in the Pharmaceutical arena
  • BS in chemistry, biology or a related scientific discipline
  • 1-3 years scientific background
  • Excellent oral communication and technical writing skills
  • Excellent interpersonal skills
  • Demonstrated attention to detail
  • Experience in GMP or GLP and/or a regulated industry (preferred)
  • Knowledge/experience with proteins and biotechnology (preferred)
  • Strong background in Microsoft applications such as Word, Excel & OneNote a must
  • Quick learner & attention to detail
  • Accepted file types: doc, pdf, txt, docx.