QA Technical Specialist Job at Synerlution, Inc
The main function is define project regulatory strategy, support as QA/Regulatory on raw material specifications, products specifications, analytical test method transfer, laboratory/process equipment qualification, cleanability evaluations, demonstration lots documentation, master Batch Reports, BOM, PRIF, formula pages, process validations protocols/reports, stability protocol and initiations, quality agreements, standard operating procedures, regulatory changes. Provide support in the evaluation of Quality aspects of the special project or other requirements.
Experience:
- Experience in Pharmaceutical / Medical Device or in a related area.
Education:
- Bachelor’s degree in a related area (Engineering and Sciences,Chemical,Biology).
Skills:
- Fluency in English and Spanish languages (written/spoken).
- Preferably experience in the field or in a related area.
- Relies on limited experience and judgment to plan and accomplish goals.
- Knowledge of commonly used concepts, practices and procedures in federal and state regulations.
- Knowledge in computer programs, Microsoft Office (word, excel)
Job Type: Full-time
Schedule:
- 8 hour shift
Work Location: One location
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