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. This position is responsible for the review of all drug product records for completeness and accuracy, to be sent to Quality Assurance for final review. The Documentation Associate II will review, approve, package and send clients Non-GMP batch records for final release. The Associate II also supports administrative responsibilities for the team, including scanning documentation, maintaining spreadsheets for in-process projects, and printing vial and tray labels.
- Reviews Drug Product records for completeness and accuracy.
- Conducts technical review of client batch record.
- Maintain project tracking spreadsheets on a daily basis.
- Monitors QA and QC databases for trending documentation.
- Supports Drug Product team members with administrative processes related to documentation.
- Maintains a GMP environment and follows all Standard Operating Procedures (SOP’s).
- 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.
- 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
- Monthly Employee Appreciation Events and Food Truck Fridays
- 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.