Document Control Specialist

JOB QUALIFICATIONS:

• Associate Degree or Bachelor’s Degree Preferred.
• Must have three years minimum of experience working in a regulated industry.
• Must be an effective communicator and understand written procedures.
• Knowledgeable in cGMPs and FDA regulations.
• Planning and organization; and ability to plan and manage multiple projects.
• Attention to detail.
• Excellent interpersonal and communication skills.
• High performance team and strong team player.
• Ability to follow routine verbal or written instructions.
• Computer proficiency: Word, Excel and Power Point.
• Able to work under pressure and meet deadlines.
• Able to work with minimal supervision.

POSITION RESPONSIBILITIES:

• Prepare, update, maintain and upload in the ERP system the Master Manufacturing Records.
• Update and maintain the Enterprise Resource Planning (ERP) on tasks related to Quality Assurance Specifications and Product.
• Issue to production department with all documents (BR, Forms, logbooks etc.) requested to complete the production schedule on time.
• Prepare, update and maintain other documents needed for the QA Department.
• Works on special projects assigned by the Manager of Quality Assurance
• Assists with issuance, review, revision, and archiving of all quality documentation.
• Assist with managing and tracking, change control, specifications, validation protocols/report, work instruction and Deviations/investigation in agile.
• Locate, and update database for documents requested by Validation, Audits and Manufacturing (COA, BRs, AQLs, Reports).
• Receiving, filing and log in original documents, Chart records, executed BRs, logbooks.
• Run Oracle reports for completed training and approve all CRNs requested by system notification.
• Updating format and reviewing of the current procedure for overdue documents and creating the CRNs to facilitate their approval.
• Create and send Issuance of notification for BR, WI, SOP and Validation Protocol

PHYSICAL REQUIRMENTS:

• Complies with all Company policies and procedures, including safety rules and regulations
• Work is performed in a standard office environment
• Subject to standing, walking, bending, reaching, stooping, and lifting of objects up to 25 pounds