Quality Assurance Manager

  • location: Kinston, NC
  • type: Permanent
  • salary: $105,000 - $110,000 per year
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job description

Quality Assurance Manager

job summary:
Assure compliance of the plant processes and products to established industry standards, specifications, and procedures, ensure quality system is implemented and its integrity maintained.

 
location: Kinston, North Carolina
job type: Permanent
salary: $105,000 - 110,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Directs and manages quality control, quality systems, personnel, department resources, and continuous improvement efforts to achieve the most efficient quality output as possible.
  • Manage and maintain an effective Quality Assurance program for the plant in alignment with Global Operating Procedures and capable of maintaining ISO 9001 and 15378 certification status.
  • Establish procedures and methods to comply with applicable GMP, ISO requirements and customer expectations
  • Ensures timely resolution to customer inquiries (audit findings and complaints)
  • Review customer requirements and make sure the system is in place to meet them
  • Achieves quality operational objectives by contributing information and analysis to strategic plans and reviews.
  • Conduct routine quality project management reviews with project Teams and management
  • Conduct plant Quality Management Review meetings of the plant quality system
  • Establish and monitor plant Quality Metrics used to evaluate the effectiveness of the Quality System
  • Manage Quality Staff at site to assure knowledge and execution of site Quality System
  • Assure proper use of change management associated with validated processes
  • Assure execution of internal audit program
  • Adjust in process/final sampling plans & related accept/reject criteria to ensure compliance to specification and customer requirements
  • Reviews data, analyzes results and recommends changes based upon findings and performs follow up to verify effectiveness
  • Drive continuous quality improvement projects and global harmonization initiatives
  • Identifies and determines quality improvement
  • Maintain clear communication paths with stakeholders
  • Performs other duties as assigned based on business needs
 
qualifications:
  • Strong experience with sterilization requirements and classified environments for production.
  • Superior organizational and leadership skills with ability to help team grow and thrive
  • Experience with Customer interface and meeting customer expectations.
  • Demonstrate team building and problem-solving skills
  • Ability to effectively prioritize and escalate issues
  • Working familiarity with Project Management Tools and Quality Risk Management.
  • Experience with microbiology and particulate lab testing.
  • Working knowledge of ISO requirements (15378) and Pharmaceutical Industry requirements (cGMP, etc)
Preferred:

  • Bachelor's in Science or Engineering, or commensurate experience
  • 6-10 years experience
  • Minimum six (6) years in Quality Assurance / Quality Control / Quality System
 
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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