Together, 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, 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 our greatest asset and we are committed to providing our employees with an environment that supports personal and professional growth.
We take pride in knowing our efforts are helping countless patients for years to come.
Do you enjoy working in a dynamic, inspiring team with an amazing culture?
If you do, then Ajinomoto Bio-Pharma Services is the place for you.
We are currently seeking a Supervisor MQA to support our 2nd shift operations.
The Manufacturing Quality Assurance Supervisor plays a key role in ensuring the Company’s GMP manufacturing operations continued compliance with U.S.
and international regulatory requirements by providing direct oversight to the development, implementation, maintenance, and performance of QA systems and programs.
This role is responsible for ensuring effective QA systems are maintained for lot file review, QA on the floor and production support activities, and documentation review.
2nd shift hours typically range from 2:00pm-11:30pm.
This is subject to vary.
Responsibilities: Manages disposition activities related to support services and materials to ensure compliance to internal and regulatory requirements.Facilitates the investigation of deviations and adverse events occurring during manufacturing activities.Evaluates the impact of deviations and adverse events to product quality and assigns product disposition.Reviews production batch records and associated data for product release and determines if records are within range of cGMP regulations.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.Coordinates and schedules Line Clearances and other support activities for cGMP processes.Coordinates AQL inspection of final filled product and provides oversight of disposition of visual inspection defects.Provides professional and collaborative Quality support to all internal stakeholders.Oversees and coordinates QA on-the-floor activities.Conducts training with junior staff on QA responsibilities and procedures.Ensures proper transition between 1st and 2nd shift team work responsibilities.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: Bachelor’s degree in a Life Sciences discipline or equivalent experience.Minimum of 5 years of QA experience in a regulated industry.Minimum of 1 year of leadership/supervisory experience.Working knowledge of drug development and GMP aseptic processing operations.Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade.Demonstrated ability to follow detailed directions in a laboratory environment.Detail oriented with strong written and verbal communication skills.Ability to work independently, within prescribed guidelines, or as a team member.Must be familiar with Microsoft Office applications.
We provide a Total Rewards package designed to make life better – both at work and at home.Annual Bonus Opportunities for All Employees15 Days Starting PTO (Annual Increase) Sick Time Off Volunteer Time OffPaid Parental LeaveAnnual Company Shutdown in DecemberComprehensive Medical, Dental Vision401K Company Match Immediate VestingBackup Daycare and EldercareMonthly Employee Appreciation Events and Food Truck FridaysEmployee Discount ProgramsTuition ReimbursementCasual Dress CodeWellness ProgramsCommunity Outreach Opportunities 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.