Sr. Spclst, Quality Assurance

Merck & Co., Inc., Rahway, NJ, USA

Rahway, New Jersey, USA
**
Quality risk management application
Gmp requirements for clinical and commercial supply
Documentation preparation, review & approval
** Merck & Co., Inc. is seeking a Senior Quality Assurance Specialist to support its Drug Substance and Drug Product facilities in Rahway, NJ. The role involves ensuring compliance with quality standards and regulatory requirements while providing leadership and guidance to the quality team. **

Job Summary

  • The Senior Quality Specialist is responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance, ensuring the site meets all Manufacturer’s License requirements.
  • Key responsibilities include applying Quality Risk Management, supporting production and quality compliance, managing documentation, and overseeing deviation investigations and CAPA.
  • This role involves participating in and leading quality and site projects, including New Product Introduction, and preparing for and hosting regulatory and customer audits.

Matching Summary

Match Score: 75

** Merck & Co., Inc. is seeking a Senior Quality Assurance Specialist to support its Drug Substance and Drug Product facilities in Rahway, NJ. The role involves ensuring compliance with quality standards and regulatory requirements while providing leadership and guidance to the quality team. **

Skills & Requirements

Must-have

  • Quality Risk Management application
  • GMP requirements for clinical and commercial supply
  • Documentation preparation, review & approval
  • Deviation management process
  • Change controls documentation and assessment
  • Internal audit program participation
  • Regulatory and customer audit preparation

Nice-to-have

  • Leadership and guidance provision
  • Coaching and upskilling team members
  • High performance standards setting
  • Attention to detail, accuracy, completeness
  • Energy, knowledge, motivation, innovation
  • Adaptability to changing environments

Key Requirements

  • Degree or post-graduate qualification in Science, Pharmacy or equivalent
  • Experience and knowledge of GMP Requirements for Electronic/paper free operations
  • Project Management experience
  • Validation experience

Work Rights

Not specified

Tailored Resume

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