Career Opportunities: Quality Systems Specialist (157219)
Req Id 157219 - Posted 02/06/2017 - United States - Illinois - Kankakee - Quality - Career Level (2) - full-time
- Oversee the CAPA system to ensure effective corrective and preventive actions are implemented to prevent reoccurrence.
- Monitors methods and processes for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Provide Quality oversight to off-shift production operations. Work closely with production staff to troubleshoot atypical events, identify an appropriate path forward, and properly document the event.
- Assist in the investigation of customer complaints through batch record review, trend analysis and CAPA evaluation
- Support the Supplier Quality Management (SQM) system through supplier evaluation (i.e. survey analysis, supplier quality audits, supplier risk assessment).
- Participate in Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule. CQA Certification will be required.
- Provide back-up support for additional QA responsibilities including Document Control, Batch Release, and Change Control
- Application of statistical analysis, problem solving techniques, risk assessment, and troubleshooting
- Assist validation by reviewing protocols, execution of protocols, reviewing / writing of final reports
- Provides monthly quality indicators and improves results.
- Develops standards and procedures to provide quality guidance and methods.
- Ensures that the ISO, cGMP, and USDA guidelines, corporate policies, and site procedures are followed. Backup support for document control and batch release
- Provide training as assigned
- Lives and communicates EMD Millipore values within the organization
- Bachelors Degree in a Quality or Science discipline preferred (i.e. Chemistry, Biology, or Medical Technology).
- 1-3 years progressive responsibility and experience in a drug manufacturing, medical device, or biologics industry preferred
- Understanding and application of Quality Systems and Engineering principles, concepts, practices and standards.
- Demonstrated experience in execution and management of CAPA and document control systems.
- Demonstrated familiarity in cGMPs, FDA regulations, and SOP development.
- Demonstrated basic computer skills and a working knowledge of basic computer software (Microsoft Office, MiniTab).
- Demonstrated verbal and written communication skills including the ability to conduct verbal presentations.
- Demonstrated success working in a team environment.
- Ability to travel by car and/or plane, typically up to 25%. Additional travel may be required based on business need.