Job Description

When you join Honeywell, you become a member of our global team of thinkers, innovators, dreamers and doers who make the things that make the future. That means changing the way we fly, fueling jets in an eco-friendly way, keeping buildings smart and safe and even making it possible to breathe on Mars. Working at Honeywell isn’t just about developing cool things. That’s why all of our employees enjoy access to dynamic career opportunities across different fields and industries.

Are you ready to help us make the future?
 
Advanced Materials is a global supplier of fluorine products, fine chemicals, additives, metals, films and fibers for products including pharmaceuticals, refrigeration, semiconductors and military protection. Advanced Materials is making the world safer, cleaner and enabling the modernization of a growing middle class by enhancing our customer offerings through a differentiated portfolio of chemistries, materials, value-added solutions and superior customer service. Our mission is to attract, retain and develop diverse and highly motivated, entrepreneurial employees striving to flawlessly deliver superior value to our customers every day. 

Join Honeywell as a Quality Assurance expert for a new cGMP manufacturing team. Ensure that appropriate cGMP Quality Systems are in place through review and approval of procedures including master batch records, specifications and standard operating procedures impacting the safety, identity, strength, quality or purity of the cGMP products manufactured at the site. Release or reject product based on detailed review of batch records and final product quality.  Work closely with members of the production and analytical teams to expedite completion of quality system processes including deviation investigation, CAPA and change control.  Manage cGMP document control system and training program.

Key Responsibilities:

Due to compliance with U.S. export control laws and regulations, candidate must be a U.S. Person, which is defined as, a U.S. citizen, a U.S. permanent resident, or have protected status in the U.S. under asylum or refugee status

Lead the quality assurance function
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

YOU MUST HAVE

Bachelor’s degree or 5+ years of experience in cGMP Quality Assurance related to cGMP production of drugs or drug excipients
1+ years' experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a manufacturing environment
1+ years' supervisory or management experience

WE VALUE

Familiarity with common chemical process unit operations is preferred
Experience conducting and hosting cGMP compliance audits
Familiarity with common chemical process unit operations is preferred
Experience in a fast-paced environment
Experience with managing cGMP quality processes such as deviation investigation, CAPA, change control
Experience with design, execution and reporting of cGMP validation protocols
Excellent interpersonal and communication skills
Reliable and trustworthy with highest ethical standards
Flexible to work across cultures and time zones
Understanding of industry standards and security practices
Ability to lead, motivate, develop and mentor others