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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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About Company
Science & Biotech - Durham, NC 27703

BASIC SUMMARY: Manage all technical and administrative development and execution of clinical trials/protocols for multiple and complex projects. Execute Clinical Operations functions in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs). ESSENTIAL DUTIES AND RESPONSIBILITIES: • Coordinates clinical study organization, implementation and management with the Sponsor and PharPoint Research management personnel. • Assists the Sponsor in writing laboratory specifications per study protocol and coordinating with...

View Clinical Project Manager Job - Durham, NC 27703
Science & Biotech - Durham, NC 27703

The purpose of the Director of Analytical Development is to provide the planning, development, qualification and execution of analytical assays to support internal Research & Development, Process Development and recombinant vector manufacturing. The successful candidate will have a Master’s or PhD degree in Bioanalytical Chemistry, Chemistry, Biology, Biochemistry, Virology or related field and have a working knowledge of qPCR, ELISA, SDS-PAGE/Western blot, HPLC, RP-HPLC, HPLC-SEC and cell based potency assays etc. This individual will lead an analy...

View Director, Analytical Development Job - Durham, NC 27703
Science & Biotech - Durham, NC 27703

5+ years' experience as a CRO SAS Programmer CDISC experience (SDTM, ADaM, Define.xml) Experience leading multiple studies across multiple TAs. Experience with Sponsor interaction and bid process activities Experience leading a project team Conduct QC/Validation of SAS code Expertise in SAS language options including Macro language, BASE SAS, SAS/STAT and SAS/GRAPH BS/MS Math, Statistics, Computer Science, or related field

View SAS Programmer - Remote! Job - Durham, NC 27703
Science & Biotech - Durham, NC 27707

REPORTING RELATIONSHIPS Direct reports: up to 5 DUTIES & ESSENTIAL JOB FUNCTIONS Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff Create and maintain Site Master Validation Plan Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports Release of raw materials, components, in-process materials and finished products Review and approve investigation reports as appl...

View QA Manager (GMP) Job - Durham, NC 27707
Science & Biotech - Raleigh, NC 27604

Develops and maintains pesticide product labels for submission to US EPA . Works closely with regulatory personnel to ensure labels are in full compliance with FIFRA (Federal Insecticide Fungicide and Rodenticide Act) and with state regulatory requirements. Coordinates label information with production and ensures accuracy. Essential Duties and Responsibilities: Prepare product labels for EPA submission, incorporating all required elements as per 40 CFR Part 156 and with full understanding of EPA’s Label Review Manual. Provide input for intern...

View Regulatory Label Specialist Job - Raleigh, NC 27604
Healthcare & Medical - Morrisville, NC 27650

perform DNA processing and sequencing analysis and review results from high-complexity molecular testing of human (patient) specimens under CLIA/CAP and other regulatory guidelines. They perform patient testing utilizing the molecular workflows associated with the relevant clinical diagnostic assays. Ideal candidates will have: o Experience processing human samples in a high throughput clinical laboratory. o Familiarity with molecular biology laboratory testing and analysis. o A knowledge of Clinical Laboratory Improvement Amendments (CLIA) an...

View Molecular Technologist 2nd Shift Job - Morrisville, NC 27650
MT, MLT, CLIA,