Quality Assurance Batch Release Associate
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 Assurance Batch Release Associate responsible for performing a wide variety of activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements, including assisting with audits, training programs, 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.
- Supports most quality functions and potential issues for assigned clients.
- 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.
- Assists in the training of new employees and other technical personnel.
- 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.
- 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.
- High School Diploma required. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
- Minimum four (4) years of relevant experience in documentation review, QA or equivalent.
- Minimum one (1) year of batch review experience.
- Working knowledge of GLP and cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
- Knowledge of Fill Finish and Biologics production environments strongly preferred.
- 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.
- Strong organizational and analytical skills.
- Must be familiar with Microsoft Office applications.
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.