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)
I am seeking a skilled and driven individual to fill the role of QC Specialist II at a dynamic team based in Long Island, New York. This person will play a key role in overseeing the quality and regulatory adherence of inhalation products during the entire production cycle.
Key Responsibilities:
Conduct testing on raw materials, in-process samples, and finished products to ensure compliance with DPI standards and specifications.
Utilize laboratory technologies such as HPLC, FTIR, UV-Vis, and other relevant instruments for analysis, ensuring precise record-keeping.
Review and document test results, ensuring all data complies with regulatory standards and internal SOPs (Standard Operating Procedures).
Collaborate with manufacturing and R&D teams to resolve quality issues and enhance processes related to DPI formulations and product quality.
Contribute to the development and implementation of quality control protocols for DPI products, ensuring they meet industry and company standards.
Ensure full compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Investigate discrepancies or out-of-spec results, implementing corrective actions as needed.
Qualifications and Skills:
A Bachelor's degree (BS or BA) in physical sciences is preferred.
2 - 4 years experience as a QC Chemist.
In-depth knowledge and experience working with DPI (Dry Powder Inhaler) products.
Experience with Chromatographic techniques including HPLC, GC, and UV/Vis spectrophotometer.
Experience with Dry Powder Inhaler (DPI) products or inhalation drug delivery systems.
Familiarity with particle characterization and powder processing.
Familiarity with regulatory requirements such as FDA, USP, and ICH guidelines.
Familiarity with chromatography systems is essential.
Strong organizational and English skills (reading, writing and speaking).