MEDVACON TALENT ACQUISITION, LLC has a new job opportunity looking for immediate candidates!
𝗝𝗼𝗯 𝗧𝗶𝘁𝗹𝗲
Senior Compliance and Regulatory Specialist
𝗝𝗼𝗯 𝗗𝗲𝘀𝗰𝗿𝗶𝗽𝘁𝗶𝗼𝗻
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations about the pharmaceutical industry (or regulated industry equivalent) and their impact on manufacturing processes and practices. The ideal candidate must be agile and have well-developed organizational, interpersonal, compliance, and practical application skills. This individual must be a self-starter, results-oriented with the ability to receive, compile, analyze, disseminate, and articulate data and its implications at both site and broader program levels. This role has high visibility within the Somerset site and the greater organization as it touches various functional areas including Supplier Quality, Regulatory Compliance, DEA, and QMS.
𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀
𝙀𝙙𝙪𝙘𝙖𝙩𝙞𝙤𝙣 & 𝙀𝙭𝙥𝙚𝙧𝙞𝙚𝙣𝙘𝙚
• A bachelor’s degree with at least 5+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
• Associate degree or High School Diploma with 10+ years of experience working in the pharmaceutical industry in Quality/Regulatory Compliance, Quality Assurance, Quality Management Systems or associated pharmaceutical manufacturing related function
𝙆𝙣𝙤𝙬𝙡𝙚𝙙𝙜𝙚:
• Knowledge of US FDA regulatory requirements as it pertains to solid oral dosage forms or prior experience working in a regulated field is required.
• Deep understanding of FDA and cGMP regulations pertaining to clinical and commercial pharmaceutical drug manufacturing activities is required.
• Understanding of various audit types (e.g. Customer, Supplier, Agency etc.) and techniques (e.g. Onsite, Questionnaire etc.) is preferred
• TrackWise experience is preferred.
• ASQ CQA or relevant Certification is highly preferred
𝗟𝗼𝗰𝗮𝘁𝗶𝗼𝗻
Somerset, NJ
𝗪𝗵𝗲𝗿𝗲 𝘁𝗼 𝗮𝗽𝗽𝗹𝘆
Senior Compliance and Regulatory Specialist - Medvacon Life Sciences - Career Page - https://lnkd.in/eMWDnZSe
#hiring #regulatoryspecialist #job #talent #qualitycompliance
