Senior Quality Assurance Specialist

Job Details

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.

 Germer International - Pharmaceutical Recruiting

 06/01/2024

 Piscataway,NJ