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Project Management Document Associate
Ref No.: 18-12878
Location: Canoga Park, California
Summary:
  • Responsible for converting all hard copy product Design History Files (DHF) to electronic DHFs, creating accurate indices of all documents within the DHFs, processing the eDHFs in the electronic data management system and archiving the hard copy documents.
  • This position will ensure all records are maintained in a manner compliant with company policy
  • .Responsibilities:Ensure safe and efficient handling and processing of controlled documents and document control related activities in accordance with documented standard operating procedures.
  • Create comprehensive and accurate indices of all hard copy product Design History Files.Collaborate with Project Management team on appropriate file naming convention for file retention.Scan all required files into electronic format and accurately catalog all files.
  • Process Master Control DCR(s) as assigned by Project Management team.Responsible for the routine maintenance of active and archived controlled documents and records in accordance with department SOPs.
  • Responsible for proficient initiation/coordination of Collaboration Tasks and Releasing of assigned document(s) within Master Control in a timely mannerManage and maintain off-site storage, document retention and retrieval of documents per department SOP.Support PMO department with all other misc. administrative tasks as needed.
  • This position will keep confidential all laboratory data and business information. This position must maintain a cooperative and professional relationship with all OLI staff.
Minimum Requirements/Qualifications:
  • A high school diploma minimum. Some college is desirable with an emphasis on Project Management or Biological Sciences. 1-3 years related work experience.
  • Prior work with documentation in a GMP manufacturing environment preferred.Proficient in Microsoft office, including MS Word, Excel. Knowledge of GMP document control regulations a plus.Ability to follow instructions with minimal oversight.
  • Organizational, written and verbal communication skills important.
  • Attention to detail extremely important.
  • Exercise independent discretion and judgment in execution of his/her duties.Plan and organize oneself in an efficient and consistent manner.
  • Learn new applications and procedures.This position will operate a computer terminal on a daily basis.
  • Occasional lifting of equipment of up to 35 pounds
  • Department Supervisor/Manager shall identify the required departmental training in accordance with the documented position training requirements.