Senior Advanced R&D Engineer/Scientist
Company: Disability Solutions
Location: Buffalo
Posted on: September 1, 2024
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Job Description:
Innovate high-purity, high-performance chemicals and
materialsJoin 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.
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 projectsThe
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
preferredAdditional Information
Keywords: Disability Solutions, Buffalo , Senior Advanced R&D Engineer/Scientist, Engineering , Buffalo, New York
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