Data Management Specialist II

Responsibilities

• 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.

Qualifications

• 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.