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Lori Steiner's Jobs at NeedLS
Principal and Owner | NeedLS
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Lori Steiner's Top 3 Jobs

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 - Durham, NC 27710

THIS IS A JR.-MID LEVEL ROLE 10-15% TRAVEL BETWEEN MULTIPLE SITES EXPOSURE TO SYSTEM VALIDATIONS WITHIN LAB AND MFG PHARMA ENVIRONMENTS SOLID UNDERSTANDING OF GMP ENVIRONMENT REQUIREMENTS. NO ENTERPRISE IT VALIDATION CANDIDATES. The role requires assisting in computer system validation efforts, supporting quality system governance, and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations. Responsibilities may include:...

View CSV Specialist Job - Durham, NC 27710
Science & Biotech - Morrisville, NC 27710

Overall responsibility for the management of US Regulatory Affairs matters and maintenance of NDAs relating to the approved pharmaceutical products portfolio, in support of the business goals. This includes: • Review and approval of promotional materials in accordance with labelling including oversight of filing of 2253s • Review and approval of packaging materials in accordance with labelling, and approval of artwork through partner electronic portal • Maintenance of NDAs including coordinating compilation and submission of ad hoc reports, aggreg...

View Sr. Manager, Regulatory Affairs Job - Morrisville, NC 27710