Document Control Specialist

The Document Control Specialist has responsibility for reviewing and releasing process documentation relating to the manufacturing and packaging of product based on cGMP standards and FDA guidelines.

Responsibilities include, but are not limited to: 

 Assist with organization and storage of all GMP documentation company-wide
 Review documentation as it relates to manufacturing and packaging, release of bulk and finished product to market
 Compile and review batch records
 Retrieve GMP documents upon request from in-house departments
 Maintain Document Logs / Filing System
 Assist as required with GMP audits by customers, agencies, internal 
 Help issue, track, maintain log books 
 Review Certificates of Conformance (CoCs)
 Review Change Controls
 Other projects and administrative duties as assigned by Senior Management

• Associate's Degree with minimum one year of work experience in Document Control or related department, preferably in the pharmaceutical industry
• 5+ years of work experience in pharma industry in lieu of degree
• Experience working with SOPs, cGMPs, FDA and other industry standards
• Ability to read and interpret FDA guidelines as they apply to documentation reviews
• Knowledge of cGMPs related to US FDA and EU EMEA manufacturing environments
• Knowledge of manufacturing and packaging processes
• Proficiency in Microsoft Word, Excel, graphs/charts and databases
• Ability to communicate effectively
• Ability to compile, organize and track documentation
• Extremely detail-oriented, excellent proof-reading skills with the ability to multi-task in a fast-paced environment