Job Title: Document Control Specialist
Department: Quality Assurance
The Document Control Specialist maintains aspects of the Document Control process by processing and implementing document changes for conformance to current Good Manufacturing Practices (cGMPs) and approved policies and procedures. In addition, the individual will create, process, and implement change controls in an electronic system and compile and maintain controlled records and related files to release documents to manufacturing and other departments.
Essential Job Functions
· Provide support for regulatory inspections and audits (internal and external).
· Process cGMP documents by employing thorough proofreading and editing skills to prevent errors and ensure documents conform to regulatory and company guidelines.
· Provide cGMP records management support in accordance with regulatory guidelines and company policies and procedures.
· Effectively manage documents for processing and coordinate the review and revision of procedures, specifications, and forms.
· Interact and provide support and coaching for participants in the revision process.
· Adhere to tasks provided by other departments and from within the Quality group with little supervision.
· Promote economy and efficiency in the creation, organization, maintenance, retention, use, and disposition of official records.
· Coordinate simple, efficient record retrieval requests and respond in writing to requests for information.
· Review and maintain employee training files.
· Maintain visibility and investigate regulatory compliance requirements, guidelines, and trends.
· All other duties as assigned.
· Bachelor’s Degree in Chemistry, Biology, or other science. Will consider equivalent experience and training instead of a degree.
· Minimum three years of experience in Document Control, including at least one year of relevant Quality Assurance experience in a cGMP environment.
· Must have advanced skills in MS Office, specifically Word and Excel.
· Must have technical writing experience.
· Must know about establishing and controlling manual and electronic filing systems.Apply Now