Title:  Document Control Coordinator

Job Summary

Provides documentation support for all departments, involving the preparation of batch records, assigning product lot and other numbers, issuance of laboratory notebooks, maintains all document related systems to ensure regulatory compliance in accordance to 21 CFR Part 820.40 (Document Controls) and 21 CFR 211.100(a) (Written Procedures).

Area Of Responsibility

• Compiles, prepares and distributes product and raw material batch records
• Issues, tracks, and reconciles laboratory notebooks
• Assigns product and protocol lot numbers
• Utilization of various electronic document management systems for document access and processing of documents in electronic document flow of document change requests
• Performs word processing and data entry tasks with Word documents, Excel spreadsheets
• Creates and manages documentation requests in electronic systems such as EDMS, MasterControl, and Trackwise. in a timely manner to meet established deadlines
• Creates document file folders and maintain history files
• Assists in monitoring documentation due for annual periodic review
• Maintains related database systems, logs and complete forms/records as required
• Scans documentation for filing and eventual preparation for off-site storage
• Adheres to written policies and procedures related to performing assigned tasks
• Files and performs other organizational tasks
• Regularly meets with the team to resolve issues, maintain time lines and plan in order to meet the company’s needs in the area of Document Control, Training, and Quality
• Ability to work with other department managers and document owners, and able to work independently
• Additional daily documentation tasks may be assigned by the Sr. Quality Management Systems Specialist, or the Sr. Manager, Quality Systems
• Other tasks as assigned

Work Conditions:

• Office

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, stoop, kneel, crouch, crawl, hear, and talk
• Close vision
• Operate Computer/office machines
• Lift up to 10 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• High School diploma or GED required
• Intermediate  Microsoft Office skills, including Word and Excel required
• Experience using an electronic document management system required
• Lotus Notes, MS Access, and Adobe Acrobat preferred
• Must be detail oriented with the ability to multitask in a fast paced environment
• Excellent  verbal, written and interpersonal communication skills required
• Team player with ability to collaborate with others
• Exhibits flexibility and professionalism when dealing with changing priorities and assignments
• Customer driven with sense of urgency/priority in responding to customers' needs (internal and external)
• Comprehension and awareness of the importance of achieving regulatory compliance
• Working knowledge of documentation functions within a cGMP/GDP and/or ISO regulated environment

Experience

• 2-4 years of related experience (pharmaceutical/drug, FDA regulated and/or medical device industry) preferred