
Process Improvement Specialist
4 days ago
We are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have experience in quality management, process improvement, and statistical analysis.
In this role, you will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems. This includes:
- Key Responsibilities include: initiating and completing technical activities and cost savings as part of process improvements through the update of risk documentation, procedural updates, test methods, process/software validation, etc., that have a significant impact to the business;
- Initiating, reviewing, and approving change controls;
- Performing, analyzing and interpreting statistical data using an understanding of statistical tools and methods;
- Developing a strategy and implementing appropriate sampling methods;
- Write up and review of CAPAs, NC/NCMRs and SCARs to address compliance issues and providing guidance to suppliers and engineering;
Other key responsibilities include ensuring compliance is maintained for Product Manufacturing, Packaging and Labeling; performing Internal and Supplier Audits; supporting and participating in external regulatory body audits, e.g., ISO and FDA; creating and analyzing data for Quality Metrics; complying with all relevant training required and adhering to relevant associated documentation; abiding by Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation; following strict adherence to the requirements of CGMP; actively contributing to the enhancement of compliance initiatives for areas of responsibility.
Required Skills and QualificationsTo be successful in this role, you will need:
- Strong knowledge of quality management principles and practices;
- Experience with statistical analysis and process improvement techniques;
- Excellent communication and problem-solving skills;
- Able to work independently and as part of a team;
This role offers a competitive salary and benefits package, including health insurance, retirement plan, and paid time off.
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