Data Management Specialist II - TEMP

Manage the timely, accurate and efficient preparation of controlled documents. Control the numbering, filing, storage and retrieval of documents ensuring the latest version of documents is always readily 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 promptly 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 in compiling necessary regulatory documents as needed.

The Data Management Specialist II must exhibit exceptional attention to detail and possess expert proficiency in 50% of the routine departmental tasks performed within the Document Control department.

• 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 quality management system or the manual process (paper documents).
• Verify document completeness and format requirements of manual documents submitted for implementation, ensuring adherence to established procedures.
• 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.
• Generate BOMs (Bill of Materials) in JDEdwards (ERP Enterprise Resource Planning System) for packaging and cartoning Batch Records issuance.
• 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.
• Process and monitor on-time closure of all FDA commitments to comply with FDA requests/due dates.
• Retrieve files as requested by employees. Copy, scan and file records as required.
• Assign Document numbers for Logbooks, Notebooks, Protocols, Bath Record Forms and Special Instructions. Reconcile and file Logbooks upon returned.
• Perform quality check on documentation as per document control process and identify areas for improvement.
• Manage and perform record retention activities by organizing and preparing superseded and obsolete documents for off-site storage and maintaining detailed database indexes to ensure efficient document retrieval.
• Support audits and inspections by providing and compiling copies of documentation in a timely manner.
• 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 internal customers in compiling relevant regulatory documents for submission, ensuring compliance and accuracy.
• Maintain accurate data entry of department indexes, ensuring up-to-date and reliable information.
• Collaborate with team members to identify any discrepancies in documentation and resolve issues promptly.

Competencies:

Education / Experience:

High School diploma and four 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 with professional experience. In addition, three to five years of 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), JD Edwards and Quality 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 and policy 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.

Other:

Occasional extra hours required to meet project deadlines.