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Miles
Km80.5

Senior Quality Control Analyst

La Jolla Biologics

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Location: San Diego, CA Posted Date: 3/20/2013 Position Type: Full time Job Code: 2013-006 Required Education: Bachelors Degree Areas of Expertise Desired: Analytical Chemistry
Biochemistry
Biology
Chemistry
Quality Control

Description

Summary

Responsible for sampling, testing and drafting of specifications for raw materials, release and stability testing of protein products, and execution and report writing of method qualifications and validations in a GMP setting.    

Job Responsibilities

Essential
? Sampling and testing of raw materials for GMP production.  
? Author and/or revise raw material testing procedures as needed.
? Coordination with external vendors for outsourced testing and reporting of results.
? Timely testing of process intermediates, drug substance, drug product and GMP stability samples using HPLC, CE, Mass Spectrometry, spectroscopy and immunoassays techniques.  
? GMP documentation of laboratory testing using forms and logbooks, summarizing testing results and generating certificates of analysis.
? Qualification/ Validation of analytical methods and co-authoring of reports.

Supplementary Responsibilities
? Independently writes and/or reviews standard operating procedures.
? Report writing to support clinical and commercial stability programs such as stability summaries for drug substance and drug product, justification of shelf-life extension, and reports to support global regulatory filings and regulatory responses.
? Support authoring of quality sections in NDAs and other filings for global registration.

Requirements

Education and Experience
? B.S. Analytical Chemistry, Biochemistry, Chemistry, Biology or related disciplines.  
? 6 years or more of GMP industry experience working with recombinant proteins/biologics and analytical biochemistry areas of expertise, such as: HPLC, CE, etc. and/or bioassays, raw material testing and microbial assays are preferred.

Knowledge, skills and abilities
? Demonstrates ability to recognize anomalous results and interpret experimental outcomes.
? Develop skills in data analysis and ability to evaluate quality of data.
? Willingness and ability to communicate and work flexibly is essential.
? Excellent oral, writing, and documentation skills are required.
? Requires ability to use common tools for effective scientific communication within the company
? Ability to multitask and participate in highly effective teams.
? Proficient with the following office applications: Microsoft Word, Excel, and PowerPoint.  


Work Environment/Physical Demands/Safety Considerations

? Standard office environment
? Standard Lab environment
? Clinical manufacturing environment
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