Quality Assurance Associate
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POST DATE 9/16/2016
END DATE 12/2/2016
Ajinomoto Althea, Inc.
San Diego, CA
JOB DESCRIPTIONAPPLY 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.
Ajinomoto Althea is currently seeking a Quality Assurance Associate. This is your opportunity to join the Quality team of a leading organization known for its outstanding quality record in the industry, while being a part of a great, collaborative team making an impact on countless patients for years to come.
You will perform various semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) and applicable regulatory requirements, including assisting with material disposition, audits, and documentation review.
Reviews production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
Evaluates the impact of deviations and adverse events to product quality.
Interacts with clients and follows up on client inquiries.
Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings. Assists in the writing of detailed reports and analyzes quality data.
Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
Performs logbook documentation audits for cGMP regulated logs and SOPs.
Performs Line Clearances for cGMP processes.
Creates cGMP labels, and reviews and reconciles cGMP label generation.
Embodies Althea s cultural values and aligns daily actions with department goals and company culture.