Vaccine Quality Assurance Expert
hace 1 mes
**Job Overview:**
Merck Sharp & Dohme Corp. is committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.
**Salary:** $85,000 - $110,000 per year
**Job Description:**
As a Vaccine Quality Assurance Specialist at Merck Sharp & Dohme Corp., you will play a crucial role in ensuring the quality of our vaccine manufacturing process.
**Responsibilities:**
- Ensure compliance with the Quality Systems in the vaccine manufacturing process.
- Ensure compliance with GMP regulations, our company's Quality Manual, and regulatory requirements.
- Review batch documentation of products manufactured by our company.
- Perform the pre-UD (UD) process for the release of products manufactured by our company to the market.
- Support adherence to the product release plan manufactured by our company.
- Manage Quality information and metrics.
- Manage Quality Assurance (QA) documentation.
- Create and maintain Quality master data in SAP.
- Manage specifications.
- Review and implement regulatory changes.
- Quality member in product complaints.
- Preparation and review of PQR (Product Quality Review).
- Creation, review, and approval of deviations, CAPAs, and change controls.
- Support as QA representative in the introduction or transfer of new products.
- Support as QA representative in process validation.
- Perform Quality Oversight.
- Preparation, review, and approval of risk analysis.
- Participation in external and internal audits.
- Participation in continuous improvement projects.
**Qualifications:**
- University education in Health Sciences.
- Relevant professional experience in the pharmaceutical sector (at least three years).
- Advanced English.
- Advanced knowledge of GMP regulations and regulatory requirements.
- Demonstrated ability to analyze, solve problems, and communicate effectively (oral/written) in Spanish and English.
- Experience in Quality Assurance (QA).
- Knowledge of batch documentation review and approval processes by Quality.
- Knowledge of product release processes by Quality.
- Knowledge of Quality System tools: change controls, deviation management, out-of-specification results, CAPAs, claims.
- Data management in SAP.
- Demonstrable experience in participation in projects, transfers, and audits.
**Benefits:**
We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, paid time off, and opportunities for career growth and development.
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