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!
[email protected]
+44 1293 243858