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 MQA Associate II who will support the Quality Assurance team by leading projects, training junior staff and coordinating daily activities with assistants.
The ideal MQA Associate II will provide quality oversight and support on the floor during manufacturing operations, as well as manage documentation review with junior staff and ensure documents are reviewed for completeness and accuracy.
They will also assist in the review and approval of production batch records and associated data for product disposition.
Responsibilities: Manages the documentation/data review in support of manufacturing operations (e.G.
logbooks, cleaning logs, sterilization records, stability reports, buffer batch records) with junior staff.Designated subject matter expert during AQL inspectionAssists in real-time review of documents on the manufacturing floorAssists in the review and approval of executed and non-executed lot file documentation in support of the manufacture and testing of Drug Substance and Drug Product batchesIndependently provides quality oversight of on the floor activitiesPerforms real time, on the-floor documentation review during commercial packaging and labeling activities.Sterile gown qualified to support cGMP activities in sterile suites.Oversees scheduled facility walk-throughs.Oversees material destructionReviews and approves controlled documents including standard operating procedures, protocols and reportsRegular 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 or equivalent.
Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.Minimum of two to four (2-4) years of experience in documentation, QA or equivalent.Knowledge of cGMP regulations and good documentation practices preferred.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.
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.