Senior Specialist (QA) at Merck- Lifescience Candidates Apply Now
Are you a highly skilled and experienced Quality Assurance(QA) professional with a Bachelor’s or Master’s degree in a relevant scientific or engineering field? Merck & Co., Inc. (Merck Sharp & Dohme LLC), a global healthcare company committed to improving health worldwide, is seeking a dedicated Senior Specialist Quality Assurance to join our team supporting Large Molecule Manufacturing. If you have a strong background in biopharmaceutical manufacturing, regulatory compliance, and a passion for ensuring the highest quality standards, we encourage you to apply!
Job Posting: Senior Specialist, Quality Assurance (QA) for Large Molecule Manufacturing Plant
Job Summary: Quality Assurance for Large Molecule Manufacturing plant (Drug Substance)
Key Responsibilities:
As a Senior Specialist Quality Assurance(QA) at Merck, your key responsibilities will include:
- Quality Oversight: Report to the quality lead and provide general directions on quality goals and objectives.
- Regulatory Compliance: Ensuring adherence to and compliance with all applicable regulatory requirements throughout the product lifecycle.
- Manufacturing Support: Providing ongoing quality support to External Partners involved in large molecule manufacturing.
- Collaboration: Working collaboratively with Biologics (QA), Quality Operations, and other relevant cross-functional teams.
- Validation Strategies: Supporting and overseeing the development and execution of validation strategies for new and existing products and processes.
- Technical Review: Conducting thorough technical reviews of External Partners’ manufacturing processes and procedures.
- Issue Resolution: Effectively troubleshooting quality-related manufacturing issues and actively supporting investigations to determine root causes and implement corrective actions.
Education Minimum Requirement:
Bachelor’s or master’s degree in Chemical/Biochemical Engineering, Biotechnology, Microbiology, Pharmaceutical Science, Life Sciences, or a related field.
Required Experience and Skills of a Senior Specialist:
Proven experience working in highly regulated manufacturing environments, (QA), preferably within the biopharmaceutical industry.
- Strong knowledge of quality systems, regulatory compliance frameworks, and quality assurance practices.
- Extensive experience in process validations and a thorough understanding of associated quality documentation requirements.
Preferred Experience and Skills of a Senior Specialist:
- Familiarity with digital manufacturing processes and quality management systems within biologics production.
- Experience working with quality management software and data analysis using quality metrics.
Employee Status: Regular
Travel Requirements: Flexible
Flexible Work Arrangements: Hybrid
Job Posting End Date: 04/25/2025
Keywords: Senior Specialist, Quality Assurance, Large Molecule, Manufacturing Plant, Biopharmaceutical, Quality Systems, Regulatory Compliance, Biologics Production, Senior Specialist (QA)
