Why join Ajinomoto Bio-Pharma?
Our mission is to help improve the health of humankind.
We are a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India providing comprehensive development, cGMP manufacturing, and aseptic fill finish services. We pride ourselves in offering a unique environment in which the work we do every day plays a crucial role in society.
We hope to inspire employees to come to work engaged and ready to give their all. This allows Ajinomoto Bio-Pharma to meet the commitments it makes to partners, patients and employees.
Total Rewards package designed to make your life better:
We offer health benefits, annual performance bonus, generous paid time off, paid parental leave, matching 401k contributions (immediate vesting), tuition reimbursement, employee discount program and much more!
Your next career move:
We are currently seeking a Manager, Quality Assurance who provides supervision of GMP manufacturing operations, ensuring compliance with U.S. and international regulatory requirements. The Manager is responsible for the direct oversight of development, implementation, maintenance, and performance of QA systems, programs, and continuous improvement efforts. The Manager is responsible a wide variety of activities, varying in complexity, supporting quality management system (QMS) inputs and documentation and QA operational support for GXP activities, all while ensuring compliance with applicable regulatory requirements for ensuring effective systems for batch disposition, lot file review, and documentation review. This position is also required to liaise with clients and oversee QA client support activities.
- Reviews and develops QMS change control practices and policies.
- Leads program improvement initiatives and collaborates closely with stakeholders to implement solutions.
- Change control management; leads feasibility assessments and other deliverables.
- Manages and performs in-depth analysis of complex QMS documentation change requests including SOP’s, master batch records, methods, material specifications, protocols, and reports as well as GMP facilities, utilities and equipment management processes.
- Develops, monitors, and presents KPIs to senior leadership, evaluating program effectiveness and identifying improvement opportunities.
- Leads and actively participates in QMS documentation impact assessment efforts, and supports investigations as part of change management program and/or batch release.
- Key participant in inspection readiness and client / regulatory audits.
- Performs QA compliance review of batch records, validation reports and protocols.
- Creates, revises, and reviews SOPs. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Manages logbook documentation audits for cGMP regulated logs and SOPs.
- Manages the overall processes used to determine acceptability of batches for release.
- Supports investigations into objectionable conditions occurring during manufacturing activities. Ensures that effective corrective and preventive actions are implemented to prevent reoccurrence.
- Acts as the liaison between Aji Bio-Pharma’s QA department and client’s QA departments for complex processes. Provides solutions to complex problems relating to CGMP.
- Assembles, Analyzes and Delivers detailed quality assurance metrics to Sr. Leadership.
- Develops and oversees effective training processes to ensure adequate training is in place for batch disposition activities.
- Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
- 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.
- Embodies Aji Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.
Bachelor’s degree in a Life Sciences discipline or equivalent.
Bachelor’s degree and a minimum of 5yrs. of relevant experience or 7 years of equivalent QA experience in a regulated environment.
Minimum of 3 years of leadership/supervisory experience.
Strong knowledge of drug and/or device development and CGMP production.
Experience with aseptic processing operations and/or biologic processes preferred.
Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
Detail oriented and strong written and verbal communication skills.
Proven ability to successfully manage multiple complex projects.
Ability to effectively lead a team and work independently, within prescribed guidelines, or as a team leader or member.
Must be proficient with Microsoft Office applications.
The anticipated salary range for candidates who will work in California is $100,737.64 – 141,032.70
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the job, type and length of experience within the industry, education, etc. Ajinomoto Bio-Pharma Services is a multi-state employer and this salary range may not reflect positions that work in other states.
If you meet the requirements above, and would like to apply for this position, please visit our website at www.ajibio-pharma.com and click on the "Careers" section. Please be sure to note where you saw our ad posting.
New hires will 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.