Job Description

Job Description

Job Description

This is an approximate 1-year, 40 hour per week (Monday through Friday from 8 am to 5 pm) temporary assignment. Candidates must be within close proximity to Exton, PA, and able to work onsite up to 3 days per week. May be more, as needed. 

Scientific background, ideally pharma experience.

Job Qualifications
• BS in Chemistry, Biology or a related scientific discipline.
• At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
• Proficient in scientific/technical writing.
***Experience in Empower chromatographic data system
• Experience with LIMS, SAP/SRM, TrackWise, and Veeva.
• Excellent oral communication, interpersonal and technical writing skills.
• Excellent organizational skills, demonstrate attention to detail.
• Experience in GMP/GLP and/or a regulated industry.
• Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
• Advanced Excel knowledge is a plus.

Job Description
• Author technical reports, policies, and Standard Operating Procedures.
• Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
• Author investigations, deviations, change controls, and other non-conformance records.
• Work with vendors to coordinate testing and arrange shipments as needed.
• Compile and review scientific data for completeness as needed.
• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
• Use of LIMS database including protocol setup, data entry/approval, and data trending.
• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
• Coordinate document review, approval, and archiving.
• Participate in analytical testing lab activities, on an as needed basis. Company Description

UserEdge, 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.

Company Description

UserEdge, 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. \r\n\r\nFor 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.

Job Tags

Permanent employment, Contract work, Temporary work, 3 days per week, Monday to Friday,

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