Associate Director overseeing Quality Assurance group for pharmaceutical manufacturing. Implementing cGMP practices and managing compliance for Devens and North Andover sites.
About the role
- QA Tech executing quality tests and supporting engineering and production departments at West. Ensuring compliance with quality standards and assisting in document maintenance and customer interaction.
Responsibilities
- perform a variety of tasks and conducts test procedures in regard to 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
- Receiving and inspection of incoming goods and materials
- Ensure that all parts/materials which require incoming inspection 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
- Assist in problem resolution with customers
- Perform periodic audits as requested and complete necessary documentation
- Archive quality records, samples and log procedures
- Make periodic clean-out of records and samples exceeding minimum retention requirements
- Batch paperwork review and final decision to release product for shipment
Requirements
- High School Diploma or GED Required
- 3 years of job-related experience in QA/QC and the use of measuring equipment
- understanding the principles of Batch Control and FIFO
- knowledge of GMP
- Computer literacy required
- Ideally have a third level qualification in Quality/Mechanical/Plastic Engineering and/or have relevant industrial experience in a high-volume injection-molding environment
- 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
Benefits
- health insurance
- retirement plans
- paid time off
- professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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