Quality Auditor
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Williamsport • Pennsylvania • United States
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About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
metrologyquality assurancequality controlstatistical samplingbatch controlFIFOGMPinjection moldingISO 9001ISO 13485
Soft Skills
communicationinterpersonal skillsdetail orientedorganizedflexibletime managementproblem solvingteam collaborationauditingdocumentation
Certifications
High School DiplomaGEDAssociates Degree in MetrologyQuality related fieldsthird level qualification in Quality EngineeringMechanical EngineeringPlastic Engineering