Quality Compliance Associate Analyst - NJ in Branchburg, NJ at Apex Life Sciences

Date Posted: 5/15/2018

Job Snapshot

Job Description


Quality Compliance Associate Analyst 

DESCRIPTION:

  • Under management supervision, the Quality Compliance Associate Analyst will support all aspects of the Quality Compliance processes, including monitoring of applicable standards/regulations and facilitating the assessment of standards/regulations for changes impacting the business; monitoring internal audit records to ensure timely closure, supporting external inspection activities as needed and maintaining compliance files and tracking databases. 

KEY DUTIES AND RESPONSIBILITIES: DESCRIBE SCOPE: 

  • Support the control of external standards/regulations process by: 
    • Monitoring external standards/regulations applicable to the business; 
    • Facilitating the assessment of standards/regulations for changes impacting our client; 
    • Facilitating the review and approval of standards/regulations gap assessment forms; 
    • Ensuring remediation of gaps identified during the assessment is completed.  
  • Monitor the Internal Audit TrackWise system to ensure that internal audit records, including observation, response and action records are assigned and completed timely. 
  • Support the management of external inspections by ensuring adequate resources (e.g. meeting rooms, general logistics, equipment, personnel) are available for inspections and performing any inspection readiness activities as required. 
  • Maintain compliance files and tracking databases.

POSITION QUALIFICATION REQUIREMENTS 

BASIC QUALIFICATIONS: 

  • BA/BS in Technical Field is required. 
  • Excellent technical writing and verbal communication skills. 
  • Experience with MS Office applications including Word, Excel, PowerPoint presentation & Outlook. 

PREFERRED QUALIFICATIONS: 

  • Knowledge of relevant regulations/standards, i.e., ISO13485, FDA 21CFR820, FDA 21CFR1271, AATB, etc.