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 an Assistant Technical Writer – Drug Product Packaging. You will under direct supervision, this position investigates, authors, coordinates, and revises deviations, preventative actions, change controls, and other related cGMP documents. The Assistant Technical Writer supports simple write-ups and the resolution of issues or risks related to Drug Product Packaging and Supply Chain. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation.
- Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations. May support cross-functional teams.
- Authors and revises compliance, change controls, and other technical documentation.
- Manages specific components of large-scale deviations.
- Tracks and trends relevant documentation and data as specified.
- Maintains a GLP/cGMP environment and follows SOPs.
- Adjusts responsibilities and activities to meet client and internal expectations.
- Follows up on open documents to ensure timely close out of investigations.
- Provides support to internal and client audits as needed.
- Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
- 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 Ajinomoto Bio-Pharma Services’ cultural values and aligns daily actions with department goals and company culture.
- Associate’s or Bachelor’s degree preferred. High School diploma or equivalent required.
- 0-2 years of relevant experience in manufacturing.
- Minimum of 1 year of relevant experience in cGMP environment preferred.
- Previous investigations experience preferred.
- Familiarity with relevant technical documentation (SOPs, preventative actions, deviations, etc.) preferred.
- Detail oriented with strong English writing skills.
- Strong verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Highly proficient 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 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.