Quality Assurance Group Lead - Batch Record Review

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 QA Group Lead who will be responsible for performing a wide variety of semi-routine, moderate to highly complex activities pertaining to assuring compliance with applicable regulatory requirements, providing QA oversight of manufacturing operations, documentation and record management, facility and equipment management, change controls, investigations, and support of validation activities. Responsible for coordination and coaching of junior QA staff to resolve issues and ensure compliance with applicable regulations and client requirements.

Responsibilities:

· Leads the review and approval of executed technical documentation in support of the manufacture and testing of Drug Substance and Drug product.

· Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.

· Coordinates and schedules quality functions to support cGMP processes.

· Supports cGMP activities by providing oversight, guidance, and quality decision making.

· Communicates shift team status to other team leaders within QA and other cross functional departments as needed.

· Monitors and communicates team metrics.

· Coaching cross functional team members to ensure compliance with internal documents and applicable regulations.

· Independently investigates, troubleshoots, and rectifies issues as a result of QA analysis.

· Performs review of production records and associated data to ensure compliance. May be responsible for batch approval/rejection.

· Provides training, leadership and guidance to QA personnel.

· 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.

Requirements :

· High school diploma required.

· Bachelor’s degree in Life Sciences discipline or equivalent strongly preferred.

· Minimum of two (2) years (with degree) or four (4) years (without degree) of relevant experience in documentation review, QA, or equivalent.

· Minimum of one (1) year of functional leadership experience desired.

· Working knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines and good documentation practices.

· Knowledge of cGMP operations within medical device or pharmaceuticals. Fill Finish and Biologics production environments is preferred.

The anticipated hourly range for candidates who will work in California is $29.52 - $41.33.

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.

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