Title: Pharmaceutical Stability LIMS Consultant
Location: Exton, PA
Term: 1 year – potential to extend
Candidates must have extensive experience with Stability LIMS in Pharmaceuticals.
· LABVANTAGE PREFERRED, WILL CONSIDER LABWARE or OTHER LIMS/Stability Expertise
· 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
• 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
For JOB CANDIDATES we have direct relationships with hiring managers! Also, we can provide better insight into open job roles as well as present your resume directly in front of the hiring manager.
UserEdge Technical PersonnelUserEdge, founded in 1995, is a boutique agency providing mid to large-sized companies with direct hire recruitment, contract-to-permanent hire, as well as contract staffing primarily in New Jersey, New York and Pennsylvania. We are a highly specialized agency and our core focus is in Training (instructional design, eLearning, training, etc.), User Experience (Web visual design, UX design, UX research, etc.) and Documentation (technical writing, marketing communications, regulatory documentation, etc.), Project Management of above areas as well as Business Analysis. For JOB CANDIDATES we have direct relationships with hiring managers! Also, we can provide better insight into open job roles as well as present your resume directly in front of the hiring manager.