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Documentation Coordinator II

Branchburg Township, New Jersey Anzeigen-ID 2207769 Kategorie Manufacturing & Operations Bereich AbbVie

 

This position is responsible for managing all Branchburg Quality Records, such as production donor, batch, and medical device records. Working with other departmental personnel, the Documentation Coordinator will maintain and file records, as well as maintain the file room. This position will prepare, process, and sustain storage of in-house and offsite records, as well as support the creation of electronic files of records. The Documentation Coordinator will interact with other departments, including Production, Tissue Services and Quality Control, to complete request orders of files, charts and documents.

 

 

 

KEY DUTIES AND RESPONSIBILITIES: Describe scope:

% of Time or

Importance

Support Production business needs. Complete all requests for records, such as locating & retrieving requested records. Track all records taken out of Records Management.

30%

File and maintain records and documents.   Organize paperwork and electronic records for filing; maintain an efficient file room and network system.

25%

Produce digital copies (scans) of paper documents/records. Electronic copies documents/records need to be legible and organized on company network and/or other storage devices.

15%

Follow retention process for offsite storage records. Prepare records for transportation to\from offsite facility by collecting vital record information, completing forms, packing boxes and creating an electronic record for future reference.

15%

Thoroughly carry out all relevant training in compliance with procedures, standards, regulations, and other governed bodies.

10%

Assist in internal & external audits. Maintain understanding of current regulations & guidelines related to document & change control, such as FDA Good Manufactur ing Practices, FDA Good Tissue Practices, AATB Good Tissue Practices, state regulations , ISO 9001, ISO 13485, ISO 14971 standards, local site policies/procedures, 93/42 EEC Medical Device Directive, and other applicable standards.

5%


Education and Experience

  • High School Diploma.
  • At least one year of experiencein an office environment (filing,scanning, etc.)
  • Excellent knowledge of MS Office applications including : Word, Excel, SharePoint, Outlook etc.

Essential Skills: Refer to the role detail (or similar role details), 

  • Previous experience working ina documentation/records management environment.
  • Skill in data entry performance and record maintenance
  • Knowledge of electronic and paper record archivingmethods.
  • Administrative skills, able to pull charts, files and documents for all requests in a timely manner.
  • Ability to establish and maintain effective working relationships with other departments.
  • Handles patient, customerand company confidential information with tact anddiscretion.
  • Well organized with the ability to pay attention to detail.
  • Superior ability to foster and sustain professional relationships with all coworkers and clients
  • High adaptability to changes in work pace and volume
  • Outstanding oral and written communication abilities
  • Ability to lift approximately 35 pounds while archiving documentation.
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: No
Job Type: Experienced
Schedule: Full-time
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  • Manufacturing & Operations, Branchburg Township, New Jersey, USALöschen

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