Sr. Associate, QA - Compliance
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POST DATE 9/16/2016
END DATE 11/4/2016
Ajinomoto Althea, Inc.
San Diego, CA
JOB DESCRIPTIONLet 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.
In conjunction with drug product 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.
In this visible and important role as our Sr. QA Associate Compliance, you will perform a wide variety of semi-routine, moderately complex activities pertaining to assuring compliance with applicable regulatory requirements, including assisting with audits, training programs, and documentation review.
Maintains an efficient audit and corrective action tracking system and develops detailed audit plans.
Conducts comprehensive internal and external audits in accordance with written procedures to verify the adequacy and effectiveness of procedures and processes. Prepares detailed written audit reports.
Assists in developing recommendations for corrective actions/improvements and establishing timelines.
Performs Corrective Action follow-ups ensure timely completion of corrective actions and evaluates the effectiveness of corrective actions.
Hosts customer audits. Prepares document requests in accordance with customer audit agenda.
Collaborates with internal departments to ensure effective customer audit responses/corrective actions are generated in a timely manner.
Performs Corrective Action follow-ups to ensure that commitments to our clients are completed as agreed in the customer audit response.
Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.
Conducts cGMP audits including audit preparation, execution of the audit, the audit report, and follow up to any findings.
Writes detailed reports and analyzes quality data. Generates quality systems metrics for management review.
Creates, revises, and reviews SOPs. Maintains GMP environment and follows SOP s.
Processes compliance documentation initiation, revisions, and deletions.
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.
Embodies Althea s cultural values and aligns daily interactions with department goals and company culture.