Document Control Specialist *PC

Your Tasks:

This position plays a central role in the Quality Assurance Department by creating, tracking, and maintaining technical documentation for Quality and Operations functions. This position will ensure records are organized, indexed, and maintained in a centralized location to ensure ready access as needed to contribute to the overall consistent quality of products. This position supports the implementation of the company's quality systems in compliance with cGMPs and other company policies and may support client activities as assigned.

Essential Duties and Responsibilities:

• Document Management:
  • Process Document Change Orders (DCO), create/review/revise GxP documents in Master Control for format and grammar, and performs edits.
  • Issue controlled documents i.e. production records, QC Test forms, Logbooks, Lab Notebooks, protocol numbers, controlled labels for final product.
• Records Management:
  • Manage controlled documentation archives and off-site long term archival storage.
  • Support archive users by performing database searches, file retrieval and photocopying as needed.
  • Scan completed documents such as notebooks, completed batch records and other documents as required.
• Act as a SME during internal/external audits for quality and compliance in respect to documentation standards related to Quality System Documents.
• Provide training and assistance to site functions for documentation standards, Document Change Controls when handling GMP documentation and product documents whether it is in the paper based or electronic system.
• Demonstrate proficiency in daily critical/analytical thinking and decision making in regard to documentation process.
• Drive continuous improvements. Lead, facilitate and participate in initiatives on general documentation standards regarding Quality systems.
• Oversee Master File Management including maintenance of master documents
• Issue and maintain controlled copies to ensure current and effective document is used.
• Facilitate the Periodic Review and track documents to ensure processes are followed.
• Manage Master Control Doc Admin activities such as retiring controlled docs; lead training for creating /revising documents and provides; metrics and reporting)
• Support Audit/Inspection Program. Provide support to functional departments for information/Master Control system upgrades and configuration changes. Write/review and/or assist with investigations and follow-up to nonconformance's and CAPAs.
• Collaborate with Master Control Systems Administrator in the Master Control lifecycle management and other Quality projects.
• San Jose – Interact with clients to obtain review and approval of customer.
• Coordinate activities internally and externally.

Requirements:

• Bachelor’s degree with a minimum of five years’ experience in a GMP environment or equivalent combination of education and experience.
• Thorough understanding and use of Microsoft Office Suite and Adobe Acrobat.
• Experience with electronic document and/or quality management system and technical writing capabilities preferred.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel;

reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the…