Morristown, NJ, 07960, USA
3 days ago
Quality & Regulatory Affairs Specialist
Description The salary for this position is 77,000 - 87,000. Benefits: The opportunity to work in a growing, innovative environment within the pharmaceutical industry. detail oriented growth and development in a compliance-focused team. Competitive compensation and benefits package We are looking for a dedicated Associate to play a key role in ensuring compliance with quality and regulatory standards within the pharmaceutical industry. Based in Basking Ridge, New Jersey, this position offers an exciting opportunity to contribute to the delivery of high-quality generic pharmaceutical products. The role is ideal for individuals passionate about maintaining regulatory excellence and driving quality management initiatives. Responsibilities: • Ensure adherence to FDA Good Manufacturing Practices (GMP) and other regulatory standards within the pharmaceutical manufacturing process. • Collaborate with cross-functional teams to implement and maintain quality management systems. • Conduct regular audits and inspections to monitor compliance with established protocols and industry regulations. • Provide support in the preparation and submission of regulatory documentation to relevant authorities. • Identify areas for improvement in quality processes and recommend actionable solutions. • Work closely with internal stakeholders to address compliance issues and implement corrective actions. • Stay updated on changes in regulatory requirements and ensure policies and procedures reflect the latest standards. • Assist in training team members on quality and compliance-related topics to promote awareness and adherence. • Contribute to the development and review of quality assurance documentation, including SOPs and guidelines. • Support the resolution of quality-related challenges to maintain product integrity and customer satisfaction. Requirements • Bachelor’s degree in a relevant field such as Pharmaceutical Sciences, Chemistry, or a related discipline. • Strong knowledge of FDA GMP regulations and quality management systems. • Proven ability to collaborate effectively with diverse teams and stakeholders. • Experience in conducting audits and preparing regulatory documentation is preferred. • Excellent attention to detail and problem-solving skills. • Strong organizational and time management abilities to handle multiple tasks. • Familiarity with the generic pharmaceutical industry is a plus. • Effective communication skills, both written and verbal. Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles. Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app (https://www.roberthalf.com/us/en/mobile-app) and get 1-tap apply, notifications of AI-matched jobs, and much more. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information. © 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to Robert Half’s Terms of Use (https://www.roberthalf.com/us/en/terms) .
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