Document Support Specialist

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Job Description:

The Document Support Specialist supports all areas in a complex, integrated, production environment. The individual(s) selected will have attention to detail, a positive attitude, a strong work ethic, be a self‑starter, and have the ability to manage multiple priorities.

Job Requirements

• Process site master record changes in accordance with applicable standard operating procedures (SOPs) and safety guidelines, as well as applicable regulatory standards, such as current Good Manufacturing Practices (cGMPs).
• Process site documentation changes in accordance with applicable standard operating procedures (SOPs) and safety guidelines, as well as applicable regulatory standards, such as current Good Manufacturing Practices (cGMPs).
• Create and monitor change control for documentation creation/revision.
• Ability to work well and communicate with operators, supervisors, and technical support.
• Gown as appropriate and work in production as necessary to take pictures, understand the processes, accurately document operator steps.
• Ability to gain access to and navigate systems used for change control, documentation storage, and master records.

Education and Experience

• H.S. Diploma or equivalent required.
• Technical Writing or Documentation experience in a regulated industry.
• Experience with MS Office, specifically Word, Visio, and Excel is required.
• Previous manufacturing or packaging experience is a plus.
• Knowledge of SAP.

Physical and Time requirements

• Prolonged periods of sitting.
• Gowning, as required by production areas.
• Must not be penicillin or cephalosporin sensitive.

Hours - Primarily day shift. Flexible hours may be required.