**IT IS A NON-NEGOTIABLE REQUIREMENT THAT CANDIDATES HAVE DPI EXPERIENCE.**
(please do not apply if you do not have this experience as transferrable experience will not be considered)
Location: Smithtown, New York
Position: QC Chemist II (DPI)
I am looking for a talented and motivated QC Chemist II to join a fantastic team in Long Island, New York. This individual will be responsible for ensuring the quality and compliance of Dry Powder Inhaler (DPI) products throughout the manufacturing process.
Responsibilities:
Perform Quality Control (QC) testing on raw materials, in-process samples, and finished products to ensure adherence to DPI standards and specifications.
Utilize laboratory equipment and instruments such as HPLC, FTIR, UV-Vis, and other relevant technologies to conduct analysis and maintain accurate records.
Review and document all test results, ensuring compliance with regulatory requirements and internal SOPs (Standard Operating Procedures).
Collaborate with manufacturing and R&D teams to address quality concerns and optimize processes related to DPI formulations and product integrity.
Support the development and implementation of quality control procedures for DPI products to meet industry and company standards.
Ensure strict adherence to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Troubleshoot and investigate discrepancies or out-of-specification results, driving corrective actions when necessary.
Qualifications:
Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related field.
2-4 years of experience in a QC role, preferably with experience in pharmaceuticals or DPI products.
Knowledge of DPI formulation, manufacturing, and analytical techniques.
Familiarity with regulatory requirements such as FDA, USP, and ICH guidelines.
Strong problem-solving and communication skills.
Ability to work independently and as part of a team in a fast-paced environment.
Preferred Qualifications:
Experience with Dry Powder Inhaler (DPI) products or inhalation drug delivery systems.
Familiarity with particle characterization and powder processing.
Experience in using laboratory equipment such as HPLC, GC, and UV/Vis spectrophotometer.