Honeywell Senior Advanced RD Engineer/Scientist 

United States 

102988568

Responsibilities

• Manage the cGMP Quality System to meet requirements of FDA 21 CFR Part 211 and 21 CFR Part 11.

• Final responsibility and authority to approve or reject HON cGMP product

• Oversee activities concerning customer complaints and/or adverse events that include performing prompt investigations, instituting corrective actions where appropriate and identifying trends.

• Notify senior management of significant product quality issues and coordinate response

• Manage training matrix

• Interface with cGMP Customers and regulatory agencies as necessary

• Review, approve and uphold internal and external quality agreements

• Execute cGMP document control procedures

• Conduct and host internal and external cGMP quality system audits

• Coordinate quality system improvement projects

The annual base salary range for this position is $118-$148. Please note that this salary information serves as a general guideline. Honeywell considers various factors when extending an offer, including but not limited to the scope and responsibilities of the position, the candidate’s work experience, education and training, key skills, as well as market and business considerations.

YOU MUST HAVE

•Bachelor’s degree in Chemistry, Chemical Engineering, or Quality Assurance management, Advanced degree is preferred.

•5+ years of experience in cGMP Quality Assurance related to cGMP production of drugs or drug excipients

•2+ years of experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant

•2+ years of experience in conducting and hosting cGMP compliance audits

WE VALUE

•Experience in a fast-paced environment

•2+ years of experience with common chemical process unit operations is preferred

• JOB ID: req459119
• Category: Engineering
• Location: 20 Peabody St,Buffalo,New York,14210,United States
• Exempt
• Due to US export control laws, must be a US citizen, permanent resident or have protected status.