QUALITY ASSURANCE SPECIALIST

Job Description Join our team at our company, where we are committed to delivering innovative health solutions that advance the prevention and treatment of diseases in people and animals.
As a Quality Assurance Specialist, you will play a crucial role in ensuring the quality of our vaccine manufacturing process.
This is an exciting opportunity to contribute to our mission of using leading-edge science to save and improve lives around the world.
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, Usage Decision) 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.
Preferred - Knowledge of manufacturing processes, equipment, and facilities in the pharmaceutical sector, especially in the manufacturing processes of biological and sterile products.
- Knowledge of Quality Control (QC) tests.
- Experience in risk management, statistical tools, and continuous improvement methodologies.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully  Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
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Please, no phone calls or emails.
Employee Status.
Regular Relocation.
VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Not Applicable Shift.
Valid Driving License.
Hazardous Material(s).
Job Posting End Date.
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Requisition ID.
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