QA Batch Release Associate
Company: Ajinomoto Bio-Pharma Services
Location: San Diego
Posted on: February 15, 2019
QA Batch Release Associate
San Diego, CA
Quality/Regulatory - 750
Let's Make A Difference!
At Ajinomoto Bio-Pharma Services, our mission is to help improve the health of humankind. As a leading, global contract development and manufacturing organization, with sites in the US, Belgium, Japan and India, we work together to empower our clients to bring drugs to market.
Every team member at Ajinomoto Bio-Pharma Services, from manufacturing and quality programs to development and facilities services are a critical component to this effort. At our US location, our focused expertise and capabilities makes us one of the industry's top leaders for large molecule manufacturing and aseptic drug product fill in vials and syringes.
We believe our people are the greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth. We take pride in knowing our efforts are helping countless patients for years to come. If you enjoy working in a fast-paced, inspiring, and values-driven culture, Ajinomoto Bio-Pharma Services is the place for you.
Together, Let's Make A Difference.
Ajinomoto Bio-Pharma Services 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 Ajinomoto Bio-Pharma Services' 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.ajibio-pharma.cmo.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
Successful candidate must pass a background check and drug screen as a condition of employment.
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.
Keywords: Ajinomoto Bio-Pharma Services, San Diego , QA Batch Release Associate, Other , San Diego, California
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