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 Drug Product Documentation Associate II who is responsible for the review of executed Drug Product production records for completeness and accuracy. The Documentation Associate II will review, approve, and compile Non-GMP engineering batch records for disposition. The role will work with Project Managers and Subject Matter Experts to revise existing Drug Product master batch records for process change, corrective actions, and clerical document errors. The Associate II will provide administrative support, including scanning documentation, maintaining spreadsheets for in-process projects, and printing manufacturing labels

Responsibilities:

• Review of executed client and internal production batch records for drug product technical review and good documentation practice.
• Review executed Non-GMP engineering batch records for drug product technical review, finishing compilation and good documentation practice.
• Disposition executed Non-GMP batch records, including compilation of batch record, attachments, and associated forms. Deliver electronic packet to project management for recognizing revenue.
• Maintains project-tracking spreadsheets on a daily basis.
• Tracks and electronically files document errors for use in document revision.
• Utilize Quality Management systems and employee resource programs for daily tasks and collaboration.
• On-site support for Drug Product team members with administrative processes related to documentation. Scanning, label printing, and filing of process related documents.
• Revise client specific Master Batch Records for primarily for clinical production.
• Maintains a GMP environment and follows all Standard Operating Procedures (SOP’s).
• 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.

Requirements:

• High School Diploma or equivalent required; Associates degree preferred.
• Minimum of 2-4 years of relevant experience in documentation, quality assurance or equivalent.
• Familiarity with cGMP guidelines.
• Ability to work independently or as a team member.
• Must have a high level of skill using Microsoft Office applications.
• Detail oriented and strong written and verbal communication skills.

We provide a Total Rewards package designed to make life better – both at work and at home.

• Annual Bonus Opportunities for All Employees
• 15 Days Starting PTO (Annual Increase) + Sick Time Off + Volunteer Time Off
• Paid Parental Leave
• Annual Company Shutdown in December
• Comprehensive Medical, Dental + Vision
• 401K Company Match + Immediate Vesting
• Backup Daycare and Eldercare
• Employee Appreciation Events
• Employee Discount Programs
• Tuition Reimbursement
• Casual Dress Code
• Wellness Programs
• Community 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.

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