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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
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
Idea generation
Brainstorm solutions
Continuous improvement
Risk analysis
Coordinate resolution
Process definition
Auditor of process
Regulatory reviews
Cost improvement analysis
Drive technical solutions
U.S. PERSON REQUIREMENTS
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.
YOU MUST HAVE
• Bachelors degree from an accredited institution in a technical discipline such as the sciences, technology, engineering or mathematics
• 2+ years of experience in cGMP Quality Assurance related to cGMP production of drugs or drug excipients
• Experience with practical application of FDA 21 CFR Part 211 and 21 CFR Part 11 in a chemical manufacturing plant
• Experience conducting and hosting cGMP compliance audits
WE VALUE
• Bachelors degree in Quality Assurance management, Chemical Engineering or Chemistry or related industry experience
• 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
