Document Control Administrator

This position is responsible for assisting the Manager of QA/RA in the preparing, tracking, maintaining, copying and distribution of various quality reports, logs, records, and databases. This position will also support other department personnel with various administrative duties, including data entry, document preparation, inspections and complaint investigations. 

KEY RESPONSIBILITIES:  

• Assist the Manager of QA/RA in the preparing, tracking, maintaining, copying and distribution of various quality reports, logs, records, and databases. 

• Prepare, catalog, file, archive, and retrieve a variety of documents, records, and reports using electronic or manual systems. 

• Maintain QA/RA activities within the electronic database systems, including complaints, nonconformance reports, traceability, and customer required documentation packages.  

• Assist in the preparation of draft copies for Quality Management System procedures, work instructions, forms and data, via input from Manager of QA/RA. 

• Assist the Manager of QA/RA with documents required to standardize business processes, report results, satisfy regulatory requirements, and communicate with internal and external customers. 

• Understand & apply documented departmental Quality Assurance/Regulatory Affairs procedures and instructions, as well as company-wide SOPs, in execution of daily activities. 

• Support other departmental personnel with various administrative duties, data entry, document preparation, inspection, complaint investigation, etc. as assigned. 

• Other activities as assigned by the Manager of QA/RA. 

WORK EXPERIENCE:  

• One year of Document administration experience required. 

• Six years of Database Management required. 

• Relevant experience in the medical device industry is preferred. 

PREFERRED EDUCATION:  

• Bachelor's degree (B.S.) from four-year College or University preferred. 

KNOWLEDGE, SKILLS & COMPETENCIES:  

• Strong clerical aptitude, sound judgment and ability to operate with a sense of urgency in a fast-paced environment 

• Exceptionally strong computer skills (Word, Excel, Outlook, Power Point, and Internet) with the ability to learn new computer applications 

• Ability to handle simultaneous requests without losing focus or work accuracy  

• Strong oral and written communications skills 

• Ability to handle repetitive tasks 

• Ability to work independently to complete assigned tasks 

• Ability to follow standard operating procedures to perform work function 

• Strong organizational, interpersonal and team player skills 

• Motivated 

• Detail oriented 

TRAVEL / PHYSICAL DEMANDS: 

• Travel – typically not required 

• Position typically works in an office environment whether on site or remote where environmental conditions are stable 

• While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds