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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.

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. Conduct routine audits of 3 rd 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

Responsibilities

Qualifications

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

•2+ years of experience of pharma and industrial aerosol formulation development

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

•Experience with managing cGMP quality processes such as deviation investigation, CAPA, and change controls

•Experience with design, execution and reporting of cGMP validation protocols

•Lead auditor certification

•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

COMPENSATION

The annual base salary range for this position is $134,000-$167,000. Please note that this salary information serves as a general guideline. Solstice Advanced Materials 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.

BENEFITS OF WORKING FOR SOLSTICE ADVANCED MATERIALS

In addition to a competitive salary, leading-edge work, and developing solutions side-by-side with dedicated experts in their fields, Solstice Advanced Materials employees are eligible for a comprehensive benefits package. This package includes employer-subsidized Medical, Dental, Vision, and Life Insurance; Short-Term and Long-Term Disability; 401(k) match, Flexible Spending Accounts, Health Savings Accounts, EAP, and Educational Assistance; Parental Leave, Paid Time Off (for vacation, personal business, sick time, and parental leave), and 12 Paid Holidays.

The application period for the job is estimated to be 40 days from the job posting date; however, this may be shortened or extended depending on business needs and the availability of qualified candidates. Posting Date: 11/14/2025.

_Solstice Advanced Materials 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._

About Us

About Solstice Advanced Materials

Solstice Advanced Materials is a leading global specialty materials company that advances science for smarter outcomes. Solstice offers high-performance solutions that enable critical industries and applications, including refrigerants, semiconductor manufacturing, data center cooling, nuclear power, protective fibers, healthcare packaging and more. Solstice is recognized for developing next-generation materials through some of the industry's most renowned brands such as Solstice®, Genetron®, Aclar®, Spectra®, Fluka™, and Hydranal™. Partnering with over 3,000 customers across more than 120 countries and territories and supported by a robust portfolio of over 5,700 patents, Solstice’s approximately 4,000 employees worldwide drive innovation in materials science. For more information, visit Advanced Materials (https://advancedmaterials.honeywell.com/us/en) .

**Job Identification** 105891

**Job Category** Engineering

**Job Schedule** Full time

**Locations** 20 Peabody St, Buffalo, NY, 14210, US

**Hire Eligibility** Internal and External

**Relocation Package** US & CAN Domestic Tier 1