Quality Specialist

Job Title: Quality Specialist
Contract Type: Contract
Location: Charlotte, United States
Salary: USD30 - USD35 per hour
Start Date: 2018-02-26
Reference: 77652
Contact Name: Louise Fitzpatrick
Contact Email:
Job Published: February 14, 2018 23:04

Job Description

  • Job Description:  QUALITY SPECIALIST
Primary responsibilities include day to day management of the plants Quality Management System (QMS) to ensure continuing compliance with site policies, procedures and ISO 9001 requirements

This position reports to the site Quality Assurance Manager and will work closely with  Plant Operations, Laboratory and Maintenance personnel as well as Corporate Regulatory Affairs. 
  • Develop, maintain and improve the site QMS; ensure compliance with site policies/procedures and ISO 9001
  • Assist in preparing the site for transition to ISO 9001:2015
  • Revise and improve site QMS as needed to meet the requirements of RC 14001 and achieve formal certification (will partner with site Safety Manager in all activities related to RC 14001 certification)
  • Create or revise Quality Manual and/or Standard Operating procedures as needed
  • Manage Corrective Action/Preventive Action (CAPA) system; drive prompt response to open CAPAs and assure timely closure
  • Verify effectiveness of corrective actions
  • Establish process control plans
  • Evaluate process capabilities using statistical analyses
  • Perform Gage R&Rs
  • Assist Purchasing with follow-up and resolution of issues with incoming raw materials and supplier corrective actions
  • Actively lead/participate in investigations to determine root cause of non-conforming material and appropriate material disposition
  • Conduct internal audits; assist with site audits from external sources
  • Prepare customer responses to audit findings and customer complaints
  • Assist with set up and transition of site documentation from paper based system to electronic document management system
  • Prepare and conduct site QMS management review meetings
  • Prepare monthly reports for KPIs
  • QA oversight and support of production, testing and shipment of API
  • Review production lot records and analytical test results
  • Review discrepancies and change control for potential product/regulatory impact
  • Release product for shipment and complete pre-shipment inspections
  • Revise and review standard operating procedures
  • Assist with regulatory and customer audits
  • Conduct supplier audits
  • Review validation protocols and summary reports
  • Monitor key product parameters for trends; initiate Out of Trend investigations as appropriate
  • Review OOS investigations and assure errors are resolved and appropriately documented; assure data integrity in reporting of finished lot test results
  • Perform other quality related duties as identified
  • Bachelor degree in Engineering, Chemistry or other relevant field
  • 10+ years demonstrated leadership in development, implementation and management of QMS (ISO 9001 or other nationally recognized standard compliant)
  • Experience with ISO 14001 or RC 14001 preferred
  • Experience in a chemical manufacturing environment preferred
  • Lean Sigma training and the ability to utilize these tools for driving system improvements preferred
  • Trained ISO 9001 and/or cGMP auditor; minimum 5+ years auditing experience.Lead Assessor training preferred
  • Experience with management systems compliant with RC 14001 preferred
  • Ability to multi-task, prioritize and be self-directed; able to manage competing priorities and deliver results in a timely manner
  • Effective verbal and written communication skills are a must
  • Strong problem solving skills
  • Works well with all employees at all levels of the organization; team oriented
  • Decisive and able to make informed decisions that align with regulatory requirements and company policies