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
- 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
- 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)
- 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.