Senior Associate, Quality Engineering
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Walker • Missouri • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Assembly
About the role
- Provide support for the validation program for the plant or assigned functional area regarding equipment, processes or procedures used.
- Ensure compliance to regulatory and ISO Management standards.
- Responsible for compliance to West’s validation program.
- Ensure that the validation requirements are documented to provide direction for meeting the validation needs of the customers.
- Provide guidance to system/process stakeholders as to content and format of Validation life cycle documentation.
- Support Engineering and Operations groups during the process development and Validation phases of customer products’ life cycles.
- Provide required training to support qualification activities.
- Assume the QA responsibilities for reviewing and approval of validation life cycle documentation.
- Keep current with all Industry standard practices and FDA requirements for validation, change control and complaint handling.
Requirements
- Bachelor’s degree or equivalent experience in a technical discipline including Biology/Microbiology, Chemistry or Engineering.
- 6 - 10 Years of experience in Quality Systems.
- Minimum of two (2) years’ experience writing, executing and summarizing protocols.
- Knowledge of FDA, cGMP, ISO and Clean Room standards.
- Knowledge of validation of automated assembly, software, and manufacturing processes.
- Excellent written and verbal communication skills.
- Good problem-solving skills
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
Benefits
- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
validation programprotocols writingprotocols executionprotocols summarizationautomated assembly validationsoftware validationmanufacturing processes validationquality systemsISO Management standardscGMP
Soft skills
written communicationverbal communicationproblem-solvingguidancetraining