Specialist - Documentation in Columbus, OH

Onsite M-F 7:30am-3:30pm POSITION SUMMARY: Under general direction from the Director, Pharmaceutical Development and Regulatory Affairs; the Documentation Specialist is responsible for the creation/revision of the Master Packaging Records and other supporting documents related to the batch packaging record. Works within the Document Control System, Master Control on all projects. This job position is compliance critical, and responsibilities include ensuring continual and proper compliance with all division, corporate, and government regulatory requirements. It is the associate’s responsibility to observe all safety rules. Any condition thought to be hazardous or unsafe should be reported to your supervisor immediately PRIMARY DUTIES AND RESPONSIBILITIES: 1. Create and revise Master Packaging records and other documents in Master Control Document system. 2. Performs expiry dating for each batch set up. 3. Proofs Labels and Package Inserts. 4. Creates card print using barcode print HAPA software. 5. Assigns expiration dates to all batch packaging runs. 6. Performs related duties as assigned. EXPERIENCE AND EDUCATIONAL REQUIREMENTS: Normally requires four (4) years’ experience directly related to Pharmaceutical packaging and labeling and progressively responsible experience in Pharmaceutical Labeling. Experience with electronic document management systems required. Knowledge of FDA regulations/guidelines regarding labeling requirements is helpful. MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: 1. Experience in Microsoft Office, SAP, ERP systems, and Document Control System such as Master Control required. 2. Strong interpersonal skills and team player. 3. Must be able to work in a fast-paced environment and deliver projects and requests on time with respect to established timelines. 4. Excellent proofreading/editing skills

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