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Form of workJob Description
Document Control Coordinator
Provides documentation support for all operations, issuance of laboratory notebooks, and 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).
Responsibilities:
· Performs word processing and data entry tasks
· Scans and saves executes Batch Records into document management database
· Creates document file folders and maintain history files
· Assists in monitoring documentation due for periodic review
· Adheres to written policies and procedures related to performing assigned tasks
· Files and performs other organizational tasks
· Issues, tracks, and reconciles laboratory notebooks
· Coordinate the labeling and scheduling of boxes to be sent for storage offsite to Iron Mountain
· Responsible for reviewing and identifying all of the Quality documentation located in stored boxes, and to
transfer all of the content of the boxes to the site inventory spreadsheet
Requirements:
· 1-2 years of related experience (pharmaceutical/drug, FDA regulated and/or medical device industry) preferred
· Excellent verbal, written and interpersonal communication skills
· Excellent Microsoft Office skills, including Word, Excel, and PowerPoint
- High School Diploma or GED required; Degree preferred
· Good Microsoft Office skills, including Word, Excel, and MS Access
· Working knowledge of Adobe Acrobat
· Must be detail oriented with the ability to multitask in a fast paced environment
· Effective verbal, written and interpersonal communication skills
· 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
· Familiarity with an electronic data management system (EDMS)
· Working knowledge of documentation functions within a cGMP or ISO regulated environment
Provides documentation support for all operations, issuance of laboratory notebooks, and 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).
Responsibilities:
· Performs word processing and data entry tasks
· Scans and saves executes Batch Records into document management database
· Creates document file folders and maintain history files
· Assists in monitoring documentation due for periodic review
· Adheres to written policies and procedures related to performing assigned tasks
· Files and performs other organizational tasks
· Issues, tracks, and reconciles laboratory notebooks
· Coordinate the labeling and scheduling of boxes to be sent for storage offsite to Iron Mountain
· Responsible for reviewing and identifying all of the Quality documentation located in stored boxes, and to
transfer all of the content of the boxes to the site inventory spreadsheet
Requirements:
· 1-2 years of related experience (pharmaceutical/drug, FDA regulated and/or medical device industry) preferred
· Excellent verbal, written and interpersonal communication skills
· Excellent Microsoft Office skills, including Word, Excel, and PowerPoint
- High School Diploma or GED required; Degree preferred
· Good Microsoft Office skills, including Word, Excel, and MS Access
· Working knowledge of Adobe Acrobat
· Must be detail oriented with the ability to multitask in a fast paced environment
· Effective verbal, written and interpersonal communication skills
· 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
· Familiarity with an electronic data management system (EDMS)
· Working knowledge of documentation functions within a cGMP or ISO regulated environment
