Quality Control Associate, Separation SciencesAlthea Technologies, Inc. - San Diego, CA
Let’s Make Things Happen!
Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.
Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.
Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.
Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.
Althea is currently seeking a Quality Control Associate, Separation Sciences
for conducting routine and non-routine HPLC analysis. May focus in a specialized area and provide routine analysis and testing according to standard operating procedures in any of the following areas: in-process and finished formulations, in-process and purified biological products (proteins, peptides, antibodies).
Conducts routine and non-routine HPLC analysis according to standard operating procedures to support in-process, release, and stability testing in a manner consistent with cGMP requirements.
Compiles data for documentation of test procedures in a manner consistent with GDP requirements.
Analyzes data and results and presents conclusions to supervisor in tabular, graphical, and written format. Reviews data obtained for compliance to specifications and reports abnormalities to supervisor.
Assists in the transfer, qualification, and validation of new testing methods with guidance from supervisor, which may include writing protocols and reports.
Assists in investigations related to deviations and out of specification results.
Initiates revisions to current SOPs and authors new SOPs based on methodology being transferred into the QC laboratory.
Responsible for standardization and maintenance of laboratory equipment and maintains lab area.
Embodies Althea’s cultural values by aligning daily actions with department goals and company culture.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Bachelor’s degree in a Life Sciences discipline or equivalent required.
Minimum of 2-4 (two to four) years of relevant experience in a GMP setting.
Minimum of 3 (three) years of relevant HPLC experience in a laboratory setting.
Experience with GMP, FDA regulations, ICH guidelines for analytical method validation, analytical method troubleshooting, and data analysis desired.
Ability to perform testing in a highly accurate and reproducible manner.
Proficiency with Microsoft Office applications.
Detail oriented with strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions in a laboratory environment.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the Careers section. Please be sure to note where you saw our ad posting.
We are an EOE dedicated to a diverse work force and Drug Free work environment.
Qualified M/F/D/V candidates are encouraged to apply.
9 days 17 hours ago
Althea Technologies, Inc.
Please review all application instructions before applying.
Althea Technologies, Inc., based in San Diego, CA, is focused on reducing the time, risk, and overall cost of our partner's drug development efforts. We apply immediate resources, unsurpassed scientific expertise, and a vast knowledge of regulatory affairs to facilitate the progression from drug discovery to clinical approval. Althea was founded in 1998 with the purpose of accelerating drug development by providing reliable, high quality services to the biotechnology and pharmaceutical industry. With our founders' well-known expertise in gene quantification and biopharmaceutical development, we began offering custom real-time qPCR assay services and plasmid DNA production. Today, Althea has established itself as a leading provider of these highly technical services. Our continued growth has enabled us to expand our service portfolio and more than double our manufacturing capacity.
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