Quality Document Systems Specialist in El Segundo, CA at Apex Life Sciences

Date Posted: 10/6/2018

Job Snapshot

Job Description


A well-regarded company focusing on patient therapies is seeking a Quality Document Systems Specialist to join their team. This is a great opportunity to work for an industry leader!

DUTIES & RESPONSIBILITIES:

  • Support the site with preparation, circulation, and handling of all standard operating procedures (SOPs) and associated forms, and other documents as required. Other documents may include but are not limited to Specifications, Batch Records, Methods and Protocols.
  • Manage commercial GMP Document and Records Management system.
  •  Establish the process and procedures for identifying, collecting, distributing and filing the controlled documents for the site.  This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools. 
  • Manage the lifecycle SOPS and other document types utilizing a Controlled Document Management System. 
  • Provide assistance to site personnel with documentation requirements.
  • Monitor, track and report on SOPs, and other document types in various states.
  • Provide metrics on the status of SOPs and other document types to management.
  • Update and maintain reports on the procedure management process.
  • Develop new procedures and revise existing procedures as required.
  • Prioritize the completion of tasks in a timely manner.
  • Provide training of personnel on the procedure management process as required.
  • Lead document review meetings as required.
  • Other duties as assigned.

REQUIREMENTS:

  • Bachelor’s degree preferred degree or Minimum of 4+ years of experience a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility. 
  • Knowledge GMP, SOPs and quality systems
  • Excellent writing and editing skills.
  • Works on multiple assignments in collaboration with various department system owners.
  • Advanced Skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat.
  • Ability to communicate and work independently with scientific/technical personnel
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

Please send resumes to khurlbut@apexlifesciences.com

#LI-KH2

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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