R&D Documentation Coordinator - NJ in Bridgewater, NJ at Apex Life Sciences

Date Posted: 8/30/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    8/30/2018
  • Job ID:
    882219

Job Description


This is a contract role with the potential to become permanent with a global pharmaceutical company!

JOB SUMMARY: 

  • The R&D Documentation/Change Control Coordinator will facilitate and coordinate all aspects of the R&D Documentation process.
  • The position also requires the maintenance of electronic and manual archives. 

Responsibilities: 

  • Maintain filing and storage area for all R&D Study Records, Lab Notebooks, Design History Files, and Histology slides 
  • Assign R&D Study numbers 
  • Assign memo numbers 
  • Assign Lab Notebooks and perform routine Lab Notebook audits 
  • Update and maintain electronic and manual archive of lot Device History Files 
  • File and retrieve documents and files as needed. 
  • Prepare documents and lab notebooks for Off-Site storage 
  • Support the creation of new and revisions to existing documents (i.e. policies, procedures, work instructions, and forms). 
  • Support of records related issues during internal and external audits 

JOB QUALIFICATIONS: 
 

  • HS Degree 
  • Essential knowledge of MS Office (Word/Excel) 
  • 1-2 years experience working in a documentation control environment 
  • Good communications skills and ability to multi-task and work independently 
  • Knowledge of electronic document control systems 
  • Previous experience to include pharmaceutical/medical device regulated companies

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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.




882219