Sr. Assistant, Manufacturing Documentation Fill Finish

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POST DATE 9/16/2016
END DATE 11/11/2016

Ajinomoto Althea, Inc. San Diego, CA

San Diego, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Entry Level (0 - 2 years)


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 Sr. Assistant, Manufacturing Documentation Fill Finish. Use your talents of outstanding communications and attention to detail in this QA/documentation oriented role, reviewing production batch records and associated data for product release. You will interface and work closely with our project managers, quality assurance group and clients to ensure production records are written in conjunction with appropriate cGMP s and are updated as needed.

Processes compliance documentation review of both filling and inspection records as well as maintains the filing of these documents.
Ensures the completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
Final review and package of Non-GMP filling records with no QA oversight for product release.
May revise existing client production records.
May generate new client production records.
Tracks and trends documentation issues as specified.
Generates manufacturing labels for filled product.
Maintains a cGMP environment and follow SOP s.
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.