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QC Chemist

Apex Life Sciences is Currently seeking an experienced Chemist.

This is a three month contract to start, with the potential to extend much longer. The position will rotate on shifts monthly. 7p-7a and 7a-7p. Schedule is as follows: Work- M, T, Off- Wed., Thurs, Work- Fri, through Sun. then opposite the following week. The schedule will rotate monthly between 1st and 3rd. 

The QC Scientist provides moderately complex analyses in a chemistry or microbiological environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or and antimicrobial effectiveness tests. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.

Key Requirements

- Conducts moderately complex chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.

- Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.

- Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions. 

- Maintains and troubleshoots analytical instrumentation as needed.

- Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.

- Prepares and assists in filing regulatory documents in support of internal projects.  Provides communications with outside departments, corporate sites, agencies, and clients.

- Writes SOPs and other instructional documents.

- Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use. 

- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.

Qualifications

Bachelor’s degree in physical science, preferably in Chemistry or Biology.

Typically requires a minimum of 3 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples. Experience with common office software and chromatographic data acquisition systems. 

1-2 years of experience working in a laboratory, (GLP or GMP/cGMP environment preferred)

Equivalent combinations of education, training, and relevant work experience may be considered.

 

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