Documentation Associate I

Job Summary:

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).

Area of Responsibility:

• Performs word processing and data entry tasks
• Creates document file folders and maintain history of files
• Assists in monitoring documentation due for periodic review
• Updating Data base (Microsoft access) for Log books associated with ADL, QCL and employee Bond log books
• Issues, tracks, and reconciles laboratory notebooks
• Printing and distribution of requested Batch records, forms, Protocols.
• 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
• Coordinate the labeling and scheduling of boxes to be sent for storage offsite to Iron Mountain
• Collect and prepare supporting documents during Audit.
• Maintain GMP document retrieval and accessibility
• Copy Check of documents ( Batch records, Forms, protocols, and Material Specs) prior to distribution to the requester
• Adheres to written policies and procedures related to performing assigned tasks
• Attend daily production morning meetings with updates
• Scans and saves executes Batch Records into document management database
• Files and performs other organizational tasks
• Train new Document Control Associate on all tasks as per this job description
• Other duties as assigned

Work Conditions:

• Office

Physical Requirements:

• Stand, walk, sit, stoop, kneel, crouch
• Operate Computer/office machines
• Lift up to 10 lbs.

Travel Estimate: Up to 0%

Education and Job Qualification:

• 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

​​​​​​​Experience:

• 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

​​​​​​​​​​​​​​Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).