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).

If this sounds like you - Apply today!

+44 1293 243858