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Qualifications: High School Diploma/GED with a minimum of 3 years’ experience; or an Associate’s degree and 1 year of experience or a Bachelor’s degree or equivalent combination of education and experience.
- Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment.
- Demonstrates attention detail; ability to stay focused on the task at hand for long periods of time.
- Ability to effectively communicate; demonstrate a sense of urgency to complete production schedule on time; accepts personal responsibility for the quality and timeliness of work.
- Basic computer skills i.e. Microsoft Office (Word, Excel, Outlook).
- Ability to work both independently and within a team environment.
- Be an advocate for a safe work environment and be responsible for my safety and the safety of others.
- Knowledge of 21CFR Part 820, cGMPs, and ISO 9001 standards.
- Knowledge of Quality Information Systems (Windchill, SAP).
Duties & Responsibilities
- Performs a variety of product inspections, generally of finished goods, components, incoming raw materials, or new products, by observing, measuring, and recording data.
- Compares inspection results to defined requirements or specification and documents differences found.
- Makes accept/reject decision based on established guidelines and documented procedure requirements.
- Ensures that established sampling and statistical process control procedures are followed.
- Performs in process testing and identifies out of specification product.
- Makes accept/reject decision based on established guidelines, documented procedure requirements and knowledge of production. Ensures proper disposition of defective product.
- Provides technical support to quality, quality engineering and product support.
- Provides training to new and existing employees as required and reviews work of others.
- Provides support for high priority site projects.
- Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment.
- Has specialized expertise, typically developed through a combination of job-related training and considerable work experience.
- May participate in internal and external audits as SME (Subject Matter Expert) for the in-coming inspection processes.
- Occasional OT required.
Seniority level
Employment type
Job function
Industries
- IT Services and IT Consulting
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