Pharmaceutical Labeling Change Control Specialist

2 weeks ago


Collegeville, Pennsylvania, United States Pioneer Data Systems Full time

{"Job Title": "Pharmaceutical Labeling Change Control Specialist", "Job Summary": "We are seeking a highly skilled Pharmaceutical Labeling Change Control Specialist to join our team at Pioneer Data Systems. This role will be responsible for coordinating Artwork Change Control workflows for assigned products, markets, and vendors in our electronic Packaging Artwork and Labeling System (ePALMS).", "Responsibilities": ["Initiate and build Pharmaceutical Artwork Requests (PARs) using electronic artwork change management system in collaboration with local markets (PCOs)", "Negotiate Artwork Change Control logistics across multiple Pharmaceutical departments to assure Regulatory timelines for Implementation are met and that product supply is not interrupted", "Liaise with markets and stakeholders to gather all necessary information to initiate and build PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet Implementation requirements"], "Requirements": ["Bachelor's degree in a related discipline", "A minimum of 4-8+ years of related work experience, with a minimum of 2+ years of which are in a Labeling Artwork Change Control & Implementation Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related activities specifically to Artwork Change Control and Implementation", "Experience with Document Management Systems and Electronic Artwork and Labeling Management Systems", "Experience with business analytic tools such as Spotfire, Tableau, SAP Business Objects, etc.", "Experience with copy editing tools such as Acrobat Professional", "Experience with document management lifecycle tools", "Proficient in the use of Microsoft Word and Excel", "Proofreading system knowledge is preferred", "Artwork and labeling familiarity required", "FDA labeling and packaging regulation knowledge", "Experience with regulatory strategy or QA labeling/packaging preferred", "Pharmaceutical packing experience preferred", "Experience with data management systems a plus"], "Location": "This is a hybrid role, candidates must be located in either Collegeville, PA or Lake Forest IL"}



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