Compliance Specialist III - Philadelphia, United States - Pharmalearner

Description

The Product Quality Batch Release (PQBR) Manager will perform the necessary activities to ensure compliance requirements and manufacturing/release schedules are met

Position Responsibilities:
o Quality Review of Batch Recordso Preparation & Certification of Working Documentso Quality Review of Lot Release Protocol (LRP)o Compliance and Performance

Technical Competencies:
o Working knowledge of cGMPs and regulatory requirementso Knowledge of vaccines/biologics products and associated technologieso The ability to work on cross functional project teamso Meet/Exceed project timelines/deliverableso Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Officeo Strength in several LEAD Competencies Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

Soft Skills:
o Communicationo Interpersonalo Analyticalo Negotiate/Influenceo Organizationo Detail Oriented

Basic Qualifications:
o Bachelors degreeo 2+ years in a cGMP/ controlled, Quality environment in the pharmaceutical industry#J-18808-Ljbffr