Quality Assurance Compliance Specialist

LocationBrookfield, Connecticut
LocationShelbyville, Kentucky
DepartmentQuality Assurance
Position Overview

The Quality Assurance Compliance Specialist will report directly to the Quality Systems Manager.  The Specialist is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements.

Duties & Responsibilities
  • CAPA and Complaint Management
    • Subject Matter Expert of program
    • Enter and update CAPA records in ERP system
    • Review and approve root cause investigations and action plans, and provide feedback to CAPA owners as needed
    • Gather evidence and verify effectiveness of corrective actions
    • Maintain customer complaint logs
    • Review trends and communicate to Management
  • Document Change Control
    • Subject Matter Expert of program
    • Process new and revised Standard Operating Procedures, Work Instructions, and Forms through change control
    • Ensure compliance with the Triennial Document Review and process documents through change control
  • Deviation Program
    • Subject Matter Expert of program
    • Review and approve deviations and maintain deviation documentation
  • Management of Change (MOC)
    • Assist Sr. QA Compliance Specialist with completion of activities associated with the MOC program
    • Attend MOC meetings and assist project owners with completion of the MOC process
    • Gather evidence and verify effectiveness of MOCs
  • Internal Auditor
    • Conduct internal audits and write and distribute audit reports
    • Additional Quality Management System Support
    • Support Quality Systems Manager with ISO, EXCiPACT (GMP), and Organic certification audits
    • Assist Quality Systems Manager with collection of data and inputs for Quality Management Review
  • Manage and execute any assigned projects needed to support business growth.
Skills & Qualifications
  • Education: BS in science or related field
  • 2-3 years’ experience in Quality Assurance; ISO 9001 and cGMP experience preferred
  • Auditor certification such as ISO 9001 or CQA preferred
  • Proficient in Excel and Word
  • Strong communication and interpersonal skills
  • Strong organization and time-management skills
  • Proven ability to multi-task and pay attention to detail.
  • Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
  • Ability to foster collaborative, cross department relationships to meet common objectives.