Apply to this job

Back to search

Posted June 27th

Quality Systems Coordinator

New York, New York

ByHeart logo





View Full Profile

Posted June 27th

Quality Systems Coordinator

New York, New York







Role Description

The Quality System Coordinator / Administrator is responsible for providing project management and facilitation, as well as, oversight and support for the development, coordination, implementation and evaluation of quality initiatives. Main daily work is within Electronic Systems, Trackwise.

Reports To: Senior Quality Coordinator

Location: New York or Pennsylvania

Start Date: ASAP

Role Responsibilities
  • Develop skill set to become Site Subject Matter Expert for Electronic System(s). Daily management of Quality databases:
    • Primary - Trackwise System for Complaint Management (manages receipt, Inputs, tracks and completes initial complaints responses),
    • Intelex Document Control (manages procedure life cycle and system maintenance)
    • Tracegains (maintains site to ensure supplier documents are current, initiates supplier contacts)
  • Works closely with department team members to help organize department activities, schedules by becoming familiar with processes, procedures, and policies to ensure timely delivery of projects, reports and completion of information requests.
  • Batch record reviews, and dispositions:
    • Assists reviewer/approver with the collation and organization of data and production paperwork to support disposition
    • Organizes files, folders and ensures final approved documents are placed within master batch file at the facility
    • Conducts ERP Quality Transactions
  • Supports sampling requirements for department as requested
  • Follows cGMP and routinely makes decisions using cGMP/process knowledge.
  • Works with internal customers and external suppliers as requested to resolve problems and to satisfy quality and support production needs.
  • Completes assigned projects and in a timey manner
  • Tracks/reports metrics for databases.

Skills & Qualifications
  • Bachelor's degree Scientific (biology, engineering, other life science)
  • Minimum two (2) years of experience in the food industry (infant formula preferred), pharmaceutical industry or quality assurance/control
  • Capable of managing projects with minimal direction
  • Understands complaint management processes
  • Understands cGMP change control processes
  • Technical writing skills
  • Competent in computer systems and databases entry: ERP, Office (excel) and Quality related databases
  • Basic statistical understanding
  • Ability to travel domestically 5-10%
New York, New York