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Quality Specialist- Fort Lee, NJ

Company: Kedrion Biopharma
Location: Fort Lee
Posted on: November 12, 2019

Job Description:

This role is responsible for day-to-day activities of the quality assurance department. Works in a fast-paced environment supporting the Quality department functions -ResponsibilitiesMaintains controlled document systemsMaintains databases for scheduling of training, audits, document closure (change controls and deviations) and uploads documents to online systems as required Assist with CAPA and investigations to resolve quality issuesGenerates quality reports and metrics Tracks and provides information related to Quality Assurance Conducts review of batch documentation for accuracy and completeness, documenting deviations and/or failure investigation, as appropriateAssists with the generation and/or revision of GMP documentation such as standard operating proceduresSupport client audits/inspections of KedrionAssists with performing internal auditsWorks closely with Supply chain, Manufacturing, and Quality staff to resolve quality issues with regard to manufactured and/or distributed product Work closely with other departments at Kedrion and offer assistance as neededParticipates in continuous improvement initiatives to identify issues and provide recommendations for compliance improvements Coordinates training for all relevant KBI (FL) personnel on approved company policies/procedures and appropriate regulations.Other duties as assignedSkills & Technical Expertise:Familiarity with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820Exposure to applicable biological regulations (21 CFR Part 600s) or EU GPs, a -plusFamiliarity with electronic systems, including developing and producing reports using Microsoft Access and ExcelAbility to quickly learn and navigate new electronic systemsAble to work in a team setting and independently under minimum supervisionAbility to work in fast-paced environment supporting the quality department functionsCreative individual with excellent troubleshooting skillsEducation/Experience QualificationsRequires a Bachelor's Degree in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation)Requires 5 years of quality pharmaceutical experience with quality document system management experience.Demonstrated understanding and adherence to company policies, safety procedures and the cGMPsAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

Keywords: Kedrion Biopharma, Hoboken , Quality Specialist- Fort Lee, NJ, Other , Fort Lee, New Jersey

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