AVP Senior Internal Auditor at Capital Bank managing SOX compliance and internal audits. Developing audit programs and ensuring compliance with industry standards while communicating findings to management.
About the role
- Quality Auditor responsible for quality process and metrology in an inclusive healthcare environment. Collaborating with teams to maintain standards and documentation for production in Williamsport, PA.
Responsibilities
- Perform a variety of tasks and conduct test procedures regarding the quality process
- Ensure that the pre-determined high standards of quality are achieved and maintained
- Review and approval of metrology reports for batch release and validation purposes
- New product validation, analysis and reporting
- Quality support to Engineering and Production Departments
- Establish and maintain documentation in line with West Williamsport and West Pharmaceutical Services Quality Systems
- Liaise with customers and suppliers on new and existing projects
- Ensure that all parts/materials conform to all requirements and applicable drawings and specifications
- Maintain good communications both internally and externally
- Ensure that all metrology equipment is correctly calibrated
- Assist shift personnel with quality issues and/or measurement techniques
- Perform periodic audits as requested and complete necessary documentation
- Archives quality records, samples and log procedures
- Batch paperwork review and final decision to release product for shipment
- Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct
- Compliance with all Environmental, Health and Safety requirements, training and regulations
Requirements
- High School Diploma or GED Required
- Preferred Associates Degree in Metrology or Quality related fields
- 3 years of job-related experience in QA/QC and the use of measuring equipment
- Good communication/interpersonal skills
- Detail oriented, organized, flexible and able to handle multiple tasks and time critical projects/deadlines
- Understanding of the principles of Batch Control and FIFO
- Must have knowledge of GMP
- Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering
- Basic knowledge of statistical sampling of product
- Understanding of injection molding processes
- Working knowledge of ISO 9001/ ISO 13485 and FDA Code of Regulations CFR part 820 preferred
Benefits
- Supported by benefit programs
- Empower the physical, mental, emotional and financial health of our team members and their families
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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