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Data Mgmt Specialist III

4 months ago

Miami, United States Noven Pharmaceuticals Full time
Overview

Manage the timely, accurate and efficient preparation of controlled documents. Control the numbering, filing, storing and retrieval of both electronic and hard copy documents ensuring the latest version of documents is always available. Administer the data management implementation and obsolescence process of manual documentation. Manually generate production Batch Records to support Planning, Technical Services and Production operations for manufacturing runs. Respond to requests for information in a timely manner. Verify document completeness and format requirements. Direct interaction with internal customers by monitoring change requests activities in order to facilitate timely turnaround time throughout the document lifecycle. Assist internal customers with compiling applicable regulatory documents as requested. Provide system support (TrackWise Change Control and Veeva QualityDocs) to the user community. Maintain timely data entry of department Indexes.

The Data Management Specialist must demonstrate extremely detail oriented skills and expert proficiency in all routine departmental tasks performed in the Document Control Department.

Responsibilities
  • Execute tasks, including direct interaction with internal customers to assist in the review/approval and implementation process of proposed changes on, but not limited to, company-wide Policies, Standard Operating Procedures, Specifications, Standard Test Procedures, Batch Record Masters, Batch Record Forms, Controlled Forms, Process Picture Maps, Guidelines, Quality Standards, Product Control Documents and Protocols through the TrackWise Change Control System, Veeva QualityDocs System or the manual process (paper documents).
  • Verify completeness and format requirements of documentation submitted for implementation.
  • Manually issue Manufacturing (paper) Batch Records, Special Instruction, Batch Record Forms and Protocols in accordance with Production schedule. Coordinate with Planning, Technical Services and manufacturing the request and issuance of such Batch Records. Manually issue and provide additional Batch Record forms for manufacturing runs upon requests.
  • Maintain files of Master documents up to date as a result of change control activities. Perform Master file replacements and/or obsolescence; create master files; and electronic issuance updates. Manage archival activities of controlled documents.
  • Issue documentation related to projects and/or change requests activities to functional groups at Noven. Timely update appropriate document Indexes.
  • Process and monitor on-time closure of all FDA commitments to comply with FDA requests/due dates.
  • Retrieve files as requested by employees. Process and implement manual documentation. Copy, scan and file records as required.
  • Coordinate with IT department the effectiveness/obsolescence of controlled documents that impact LIMS system.
  • Coordinate with document owner/partner liaison the effectiveness of controlled documents that require partner’s approval or notification.
  • Assign Document numbers for Logbooks, Notebooks, Protocols, Bath Record Forms and Special Instructions. Reconcile, update Index and file Logbooks upon returned. Assist in the retrieval of documents.
  • Assign new numbers for those documents that reside in Veeva QualityDocs system and create placeholders for such documents. Re-assign periodic reviews, grant ownership of documents for revisions.
  • Perform quality check on documentation as per document control process and identify improvement actions.
  • Enter Knowledge Transfer Assessment (KTA) in the Learning Management System (LMS).
  • Manage and perform Record Retention activities. Create off-site storage boxes, including indexes of the content of the boxes to facilitate the retrieval of boxes as needed.
  • Support audits and inspections by providing and compiling copies of documentation in a timely manner.
  • Actively participate in daily manufacturing meetings and provide status on batch record related activities.
  • Assist management in the preparation of projects and reports as required.
  • Provide professional and efficient departmental administrative support to the department and other colleagues as necessary; support departmental investigations. Assist in compiling documents for regulatory submissions.
Qualifications

Competencies:

Education / Experience:

High School diploma and eight or more years direct Documentation Control and /or record change processing experience, or AA/AS degree and five years direct Documentation Control and /or record change processing experience, or BA degree and three years direct Documentation Control and /or record change processing experience. In addition, three to five years experience in the pharmaceutical, medical device and/or regulated industry.

Must demonstrate expert proficiency (perform efficiently with minimal errors) for all routine departmental tasks.

Demonstrate strong proficiency with PC usage in MS office applications (Word, Excel, Access, PPT, Outlook), JDE, Veeva QualityDocs, TrackWise, and Learning Management system. Exhibit excellent communication, writing, editing, proofreading and organizational skills.  Customer focused, detail-oriented, team player, work independently and able to work on multiple tasks and prioritize work. Work extended hours when necessary.  Knowledge of FDA guidelines, cGMP, regulatory requirements with the ability to read, understand, comprehend and follow SOP requirements.

Judgment / Decision Making:

Duties are performed under general direction within framework of established and routine guidelines; some modification and interpretation required.

Work Environment:

Air-conditioned office environment. Majority of time spent sitting at desk, operating computer.

Physical Demands:         

Visual acuity and manual dexterity required to proofread documents and operate computer. Ability to lift 20-pound boxes.