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Join Honeywell as a Sr Quality Assurance expert for the Buffalo 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. Conduct routine audits of 3rd party suppliers in support of GMP operations. 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 management. Manage cGMP document control system and training program. Review production, analytical, and quality records yearly and generate an Annual Product Review report. Facilitate continuous improvement through regular review of procedures, internal audits, and preventative action implementation.

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.

In October, 2024 Honeywell announced the spin-off of our Advanced Materials business to become a stand-alone publicly traded company, independent of Honeywell. Our intention is that this role, dedicated to the Advanced Materials business, will be a part of this future transaction when the separation occurs.

YOU MUST HAVE

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

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

2+ years experience of conducting and managing root cause analysis, risk assessment, CAPA, batch review and document control

• 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

Additional Information

• JOB ID: HRD244959
• Category: Engineering
• Relocation Tier: Tier 1
• Security Clearance:
• Aviation Authority (FAA for US):
• Band: 03
• Referral Bonus: 1500
• Requisition Type: Standard Requisition
• US Citizenship:
• FLSA Statement:
• FLSA CODE: Exempt

Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.