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Quality Rep
| Company | Takeda |
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| Location | Kokomo, IN, USA |
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| Salary | $60800 – $83600 |
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| Type | Full-Time |
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| Degrees | Bachelor’s, Associate’s |
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| Experience Level | Junior |
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Requirements
- Minimum of one-year relevant work experience, or an equivalent combination of education and experience.
- Relevant work experience within medical or regulated field, highly desirable.
- Demonstrated understanding of quality assurance in an FDA-regulated environment.
- Demonstrated understanding of plasma center operations.
- Effective organizational, technical and problem-solving skills.
Responsibilities
- Stays current with federal, state, local and company-specific rules, regulations, and practices.
- Ensures center compliance with all federal, state, local and company-specific regulations related to quality of product, employee and donor safety.
- Reviews operational records to ensure they are complete, accurate and compliant with cGMP requirements.
- Tracks deviations and trending in operating procedures and policies through established mechanisms.
- Identifies potential SOP revisions as needed to support continuous improvement.
- Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
- Responsible for providing feedback and developing employees in the quality department. Provides feedback during the recruitment process for quality department employees, including performance evaluations and merit increases.
Preferred Qualifications
- Previous work experience within the plasma collection industry is strongly preferred.
- Computer skills in word processing, excel, data analysis and databases highly desirable.
- Associates or Bachelor’s degree highly desirable.
