Senior Associate, Document Control

Role Summary

The Senior Associate, Document Control role is responsible for coordinating activities related to the electronic and physical record documentation, training processes and systems and administering associated SOPs and business processes that ensure compliance with established company and industry requirements.

• Support the implementation and administration of electronic and physical record documentation processes and systems, including:
• Support development of procedures, work instructions, training materials/job aides, etc., describing electronic documentation system processes and use of the electronic Document Management System.
• Serve as the document control reviewer and/or approver on documentation managed through the electronic Document Management System, ensuring documents and records comply with established procedures and requirements, appropriate functional area representatives are involved in the review and/or approval and training information is accurate, complete and appropriate training groups are assigned.
• Create, maintain, and distribute electronic document templates supporting controlled document, validation, and/or study related document development. Conduct training on use of document control templates, as needed.
• Ensure appropriate representatives receive notification and ensure proper distribution of approved and/or effective documents.
• Support in the implementation and execution of the official controlled document process through creation of official controlled copy binders to guarantee current documents may be accessed and retrieved, as needed, and ensuring appropriate representatives receive notification upon Controlled Document implementation, retirement, or obsoletion.
• Distribute official documents to internal and external customers, as needed.
• Proactively monitor and execute the document periodic review process, coordinating with appropriate functional area representatives to ensure documents are reviewed within the specified timeframe.
• Receive and archive/file executed quality related documentation and records (physical records) in a secure documentation area. Control access to documentation area(s) and track document and record submission and removal activities.
• Create, assign numbers to, and track the issuance, closure, and reconciliation of logbooks and laboratory notebooks, as needed. Maintain quality logbooks, as required, in accordance with appropriate procedures.
• Provide document system support and guidance to internal customers and expertise on document content and effective document design to authors.
• Support administration of GxP Training management processes and systems, including:
• Create electronic training profiles for new employees in accordance with submitted training requests, or as instructed by management and/or appropriate functional area representatives.
• May conduct other administration activities for the GxP Training department, as assigned.
• Identify opportunities for enhancing the overall Quality - Document Control program, process, and system, and seek input on proposed strategies and/or processes to facilitate continuous program.
• Support internal and external audit and inspection activities through retrieval and provision of requested documents and data in a timely manner.
• Perform other related duties, as assigned.

• Education & Experience:
  
  High school diploma or equivalent with 5+ years of relevant document control experience required; or Bachelor’s Degree with 3+ years of relevant document control experience required. Experience in a GMP regulated Biologics or Pharmaceutical environment preferred.

• Able to multitask across multiple functional areas, timeline-focused and flexible in work scheduling to meet the demands of a multi-product bio-pharmaceutical company
• Excellent verbal and written communication skills
• Able to communicate effectively across the organization on matters related to documentation and learning management systems
• Able to prepare written communications with clarity and accuracy
• Must be able to work independently with ability to complete routine tasks with little or no supervision
• Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, work practices, and project timelines
• Must be proficient in Microsoft Office (Excel, Word, Access, Power Point, Visio) and Adobe Professional software

• High school diploma or equivalent with 5+ years of relevant document control experience; or Bachelor’s Degree with 3+ years of relevant document control experience.

• This position works on-site in El Segundo, CA
• Light to moderate lifting is required (up to 40 pounds)
• Ability to sit at a computer terminal for an extended period of time