Document Control Administrator
- 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.
- One year of Document administration experience required.
- Six years of Database Management required.
- Relevant experience in the medical device industry is preferred.
- Bachelor's degree (B.S.) from four-year College or University preferred.
- 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 - 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
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