QC Analytical Chemist II

QC Analytical Chemist II

Malvern, PA

1 DAYS AGO

22608202

Summary

Malvern, PA

In-Person

Competitive Salary

2 Years Experience

Master's degree

No Commission

40.00 hours per week / Day Shift / Full-Time

Description

Flamma USA, LLC seeks a QC Analytical Chemist II for its 383 Phoenixville Pike, Malvern, Chester County, PA 19355 location.

As a QC Analytical Chemist II for a small molecule active pharmaceutical ingredient manufacturer and developer, the role will involve conducting GMP (Good Manufacturing Process) analyses on raw materials, in-process materials, final products, and stability samples. Also generating documentation to support the release of GMP materials. The QC Analytical Chemist II will participate in the development and validation of analytical methods and prepare related documentation. Additionally, will provide analytical support to the Process Research & Development (R D) group (Synthetic R D), collaborating on project advancements. Primarily responsible for the following:

Calibrating, maintaining and operating laboratory equipment such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Gas Chromatography-Headspace analysis (GC-HS), Fourier Transform Infrared (FTIR) analysis, pH meter, balances, Karl Fischer (KF) titration, and Liquid Chromatography-Mass Spectrometry (LCMS);

Conducting GMP analyses of raw materials, in-process materials, final product, and stability samples.

Completing GMP documentation needed to support release of raw materials, intermediates, and final products.

Validating methods for use in GMP environment.

Preparing documents such as methods of analysis, specification, analytical reports, etc.

Providing analytical support to Process R D (Synthetic R D) group and collaborating to advance the project.

Participating in method development and optimization as necessary

Requirements: Minimum of a Master's degree, or foreign equivalent, in Pharmaceutical Chemistry, Pharmaceutical Studies or a related field and at least 24 months of experience in the pharmaceutical industry, or related occupation. Must have at least twenty-four (24) months of experience with each of the following required skills: (1) Development, Validation, and Optimization of Analytical Method; (2) Method Validation Reports; and (3) Using instruments such as: High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Karl Fischer (KF) titration, pH meter, and Liquid Chromatography-Mass Spectrometry (LCMS).

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