Document Control Coordinator

Location: Thousand Oaks, CA
Date Posted: 01-24-2018
Day to Day Responsibilities:
  • Record Retrieval – Daily Number of records requested from ATO DMS in 2016: 891 (of which 75 we rejected)
  • Evaluate and process record request forms
  • Retrieve records from onsite file room or Iron Mountain (offsite storage provider)
  • Follow up with client
  • Scan and email records to clients or meet clients in file room (discourage record checkout)
  • Return record to file or archive Record Filing and Archiving – Weekly Records are delivered to ATO DMS when the business is done with them.
  • The records are manually organized, logged in to a spreadsheet and prepped for archive.
  • Log in, organize and prep records
  • QC archive forms from client
  • Create a Table of Contents for each archive box
  • Arrange for archive box pickup with Iron Mountain
  • Train clients, answer questions, provide guidance for archive process Support ATO Audit and Inspections – Ongoing
  • Be on call for immediate record requests during events
  • Deliver records to prep room
  • Fulfill all pre-work requests
  • Retrieve records from prep room post audit/inspection and re-file or return to offsite archive

Summary:
Infolinx Electronic Document Management System or other record management system within a GMP environment. Pharma or Biotech industry experience, sense of urgency, be able to work independently, must have basic/intermediate knowledge of Excel, and have good communication skills both written and verbal.

Candidate will store, manage and track company documents using Infolinx record management software. Includes responsibility to scan, image, organize and maintain documents, adhering to the company's document lifecycle procedures, and archive inactive records in accordance with the records retention schedule and business and regulatory requirements. A large part of the job is to control the retrieval of documents. Candidate will receive and process requests for records timely and accurately. This role involves being available to source and deliver records for audits and inspections throughout the year.

Assist staff with managing their records throughout the records' lifecycle by working with them to follow Amgen’s retention schedule. Provide training to staff who require database access or have responsibility for maintaining records.

Coordinate and support the activities of storing, providing access, and ensuring the secure destruction of records at the off-site records repository facility. Provide comprehensive administrative services to coordinate and maintain Good Manufacturing Practices (GMP). Responsible for managing GMP records while also ensuring their accuracy, quality and integrity. Adhere to record retention policies, safeguard information and retrieve documentation efficiently and effectively. Work style must reflect organization, accuracy and integrity when working with company documentation. Perform additional duties and projects, as assigned.

Requirements:
  • Performing data entry of records into Infolinx Electronic Document Management System.
  • Processing client requests for record retrieval and scanning, then return records to file or archive.
  • Archiving records in adherence with company procedures.
  • Must be able to organize documents and records in numerical/alphabetical order.
  • Excellent administrative skills required.
  • Excellent data entry skills required.
  • Excellent written and verbal communication.
  • Friendly, professional and able to relate well to a wide range of users.
  • Must be able to life and move boxes up to 25 lbs.
  • Follow step-by-step instructions and perform repetitive functions consistently and accurately.
  • Act as department representative to communicate and educate clients on record management processes, answer general questions, troubleshoot problems, and perform complaint resolution.
  • Work both independently and in a team environment.
  • Follow Current Good Manufacturing Practices (cGMP) regulations and Amgen policies and procedures.
  • Work in a rapidly changing and demanding environment.
  • Strong attention to detail.
  • Basic understanding of the cGMPs, as related to document requirements.
  • Help create and maintain interdepartmental training manuals (instructions).

Skills:
  • Administrative support experience
  • Experience using MS Outlook, Word, Excel, SharePoint, and PowerPoint in an office setting.
  • Must have data entry and database experience.

"This posting is for Contingent Worker, not an FTE"
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