Total Quality Senior Specialist jobs in New Jersey

Join our innovative pharmaceutical client on the cutting edge of drug development as they're gearing up for exciting advancements in formulation development and early-stage manufacturing. They are looking to add a talented Senior QA Specialist to accelerate their business. Apply to this ad to learn more!

Responsibilities:

• Collaborate closely with our formulation development team to ensure the quality and compliance of early-stage manufacturing processes, including preclinical, toxicology studies, phase I and II trials, and scale-up activities.
• Provide hands-on guidance and support to operators, transferring knowledge from the lab to manufacturing settings for processes such as hot melt extrusion, spray drying, emulsion, and suspension.
• Act as a dedicated quality resource for manufacturing, leveraging your expertise in sterile manufacturing environments to ensure adherence to regulatory requirements and industry best practices.
• Author and review batch records, SOPs, and deviations, ensuring accuracy, completeness, and compliance with relevant regulations and quality standards.
• Serve as a proactive problem-solver and "doer," driving continuous improvement initiatives and addressing deviations or issues in real-time to maintain manufacturing efficiency and product quality.

Qualifications:

• Bachelor's degree
• Experience in formulation development within the pharmaceutical industry, with a strong understanding of early-stage manufacturing processes and technologies.
• Proven ability to effectively teach and communicate complex technical concepts to operators and team members.
• In-depth knowledge of quality assurance principles and practices, with experience writing batch records, SOPs, and deviations.
• Familiarity with sterile manufacturing environments and regulatory requirements for pharmaceutical manufacturing.