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Cmc Documentation Specialist
CMC Documentation Specialist
Job Number: 281883
Description: A CMC Documentation Specialist position in Morristown New Jersey is currently available through Belcan. You will be working with the CMC Documentation Team and will be responsible for the development of Chemistry Manufacturing and Control (Module 3) documentation for the commercial products in the companys portfolio and for the creation and maintenance of regulatory CMC documents in the controlled document management system.
CMC Documentation Specialist Job Duties and Responsibilities:
• Document conversions (PDF and Excel) into Word files and proof reading of documents for accuracy.
• Loading of documents into regulatory systems and into department databases.
• Maintain timeline of projects status updates and team meeting minutes.
CMC Documentation Specialist Requirements and Preferences:
• A minimum of a High School Diploma; prefer Bachelors degree.
• Prefer proficient in regulatory and change management systems (ie. Documentum Trackwise) with one to two years’ experience in FDA-regulated industry preferably a consumer products company
• Excellent skill level in Word Excel PowerPoint Adobe Acrobat with excellent writing (data entry) and oral communication skills.
• Position requires strong organization and management skills with fluency in English; prefer additional fluency in German and/or French.
If you are interested in this CMC Documentation Specialist job in Morristown New Jersey please apply via the “apply now” link provided.
Belcan is a global supplier of engineering technical recruiting and IT services to customers in the aerospace industrial and government sectors. Belcan engineers better outcomes through adaptive and integrated services—from jet engines airframe and avionics to heavy vehicles chemical processing and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible scalable and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.
Location: Morristown NJ
Minimum Experience (yrs): 1
Required Education: High School Diploma
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