Supervisor, QA

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 Quality Assurance Supervisor that provides Quality Assurance (QA) oversight for a wide variety of highly complex GXP activities to assure compliance with U.S. and international regulatory requirements, including development, implementation, maintenance, and performance of QA systems and programs. This position is responsible for both routine and semi-routine activities that includes QA operational support oversight, quality event investigation support, document creation and review, Quality Management System (QMS) inputs, and batch release.

Responsibilities:

• Continually assesses the efficiency and effectiveness of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug product.
• Oversees routinely scheduled functions to support CGMP processes.
• Champions CGMP activities by with oversight, guidance, and quality decision making.
• Appropriately leads and coaches direct reports in confident, quality decision-making and builds depth of knowledge within assigned QA team(s).
• Establishes and communicates KPIs to senior management.
• Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis. May be required to communicate to client partners.
• Provides training opportunities for direct reports.
• Performs reviews of production records and associated data to ensure compliance. May be responsible for batch approval/rejection.
• QA collaboration and review for quality investigations (deviations, OOS, CAPAs, etc). Provide client facing quality support for unplanned events. Implement solutions and corrective actions that align with regulations and internal processes.
• Review, revise, create and approve Quality SOPs.
• Provide clear, accurate client related communications and attend client-facing meetings as needed.
• Regular and reliable attendance on a full time basis, hybrid flexibility allowed.
• 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.
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Requirements:

• Bachelor's degree in Life Sciences discipline or equivalent is required.
• Minimum of 3 years of experience in Quality with-in a regulated life sciences industry with a degree or 5 years of equivalent experience without a degree.
• Minimum of 1 - 3 years of functional leadership/supervisory experience in the life sciences industry.
• Working knowledge of drug development and GMP aseptic processing operations.
• Knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.
• Strong knowledge of GXP regulations and good documentation practices.
• Detail oriented and strong written and verbal communication skills.

The anticipated salary range for candidates who will work in California is $87,472.94 - $114,808.23 USD.

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 be asked to complete a background check and drug screen as a condition of employment.

For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO

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.

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