Sr Compliance and Regulatory Specialist - The Fountain Group
Somerset, NJ
About the Job
PAY : $53/Hr.
TEMP TO HIRE
SHIFT - MON-FRI 8:30AM-5PM
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to 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.
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
TEMP TO HIRE
SHIFT - MON-FRI 8:30AM-5PM
The Senior Regulatory and Compliance Specialist candidate must be knowledgeable in global regulations pertaining to 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.
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
Source : The Fountain Group