- Join a start-up style environment with the backing of a global company
- Exciting opportunity at growing Diagnostics company
About Our Client
Our client develops and manufactures a comprehensive portfolio of catalog and custom diagnostic quality solutions and component materials for Life Sciences organizations.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Manage site validation activities including equipment qualification, and software and process validations. Provide support during product and process validation
- Review, approve, author, and execute validation protocols and reports.
- Manage site change order process to assess and appropriately document risk including impact to internal and customer-related processes.
- Participate in and lead teams during the investigation of root cause, quality problems, and complaints using statistical techniques.
- Review and approve Document Change Requests related to materials, production processes, test methods, and quality plans as required.
- Oversee risk managment documentation.
- Initiate SOP changes to streamline, standardize, and improve quality system processes.
- Support ongoing product release activities such as review of raw material receipts, batch records, QC results, and environmental monitoring records. Assess excursions with appropriate deviations and/or risk evaluations.
- Support product stability studies through careful review of challenge conditions and requirements.
- Perform internal and supplier audits and issue audit reports
- Provide training and support for quality concepts and tools.
The Successful Applicant
- Bachelor's Degree in a scientific discipline with experience in quality engineering
- 5 + years' experience working in a cGMP or ISO 13485 environment
- Experience with Lean and/or Six Sigma concepts highly desired
- Comprehensive validation experience
- Knowledge of statistical methodologies, quality control and manufacturing operations
- Ability to strategically evaluate and implement practical, timely resolution of non-conformances, deviations, customer complaints, and CAPAs
What's on Offer
- Competitive base salary and benefit package
- Opportunity for career growth and development
- Join a start-up style Life Sciences organization with the backing of a global organization