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 Inspection Group Lead! In this position you will manage the visual inspection processes of client products. This includes offloading, counting, sample submission, inspection, labeling and packaging and other projects as assigned. The Group Lead directly provides guidance to employees to ensure operations follow SOP’s in a cGMP environment and provides general supervision over a work group, assigning tasks and checking work at regular intervals. The Drug Product Inspection Group Lead must also complete training and pass qualification testing for visual inspection of various product forms. Other key responsibilities may include interacting with outside vendors and departments, assisting in product defect/reject investigations, training operators, and writing/approving Maintenance Work Requests, Engineering and Facility Change Requests, and Purchase Requisitions.
- Manage administrative duties of direct reports such as, timecards, attendance tracking, etc.
- Projects as assigned by management.
- Ensure manufacturing documentation and areas are in an audit ready state.
- Communicate shift project status to visual inspection leaders.
- Monitors and communicates production metrics.
- Coordinate Pre-line clearance and Post-line clearance of the room with Leads and QA.
- Identify atypical trends during the product inspection process and notifying VI leadership in real-time.
- Document observational findings regarding visual inspection sequence and timing issues or anything disruptive to the inspection process such as loud noise/conversations, business related interruptions etc.
- Answer questions and coach inspectors regarding visual inspection techniques and defects in real-time.
- Recording batch record documentation and review of finished product documentation for completeness and accuracy.
- Review and verify document entries and data meets SOP and GDP requirements.
- Assigning tasks to operators as required by the project scope.
- Document and communicate with VI leadership (Supervisor and above) regarding personnel issues.
- Document the status of assigned projects at the end of shift.
- Execute any and all tasks, in Drug Product Finishing Operations, as assigned, for which they are currently qualified. Tasks include but are not limited to offloading, counting, sample submission, inspection, labeling and packaging and product transfers to Materials Management.
- May participate in the interview and selection of potential visual inspection candidates.
- Generate purchase requests for material/equipment utilized in visual inspection.
- Provide training & coaching to employees in visual inspection techniques.
- Review of finished product documentation for completeness and accuracy.
- Follow all proper gowning procedures.
- Generate work orders in electronic Maintenance system.
- 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
- High School Diploma or equivalent required.
- Bachelor’s degree in a Life Sciences discipline or equivalent training and experience preferred.
- Minimum of one (1) year of experience in Visual Inspection.
- Working knowledge of sampling of finished product and LIM’s submission
- Working knowledge of Bulk Packaging and/or Labeling of Vials / Syringes and/or Product off-loading.
- Ability to pass Project Organizer qualification exam.
- Ability to pass visual acuity exam according to SOP guidelines
- Ability to pass visual inspection qualification exams according to SOP guidelines.
- Strong knowledge of Finishing Operations and related GMP requirements.
- Detail oriented with strong written and verbal communication skills.
- Confidence and patience in all communications.
- Demonstrated ability to follow detailed directions in a laboratory/manufacturing environment.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Champions Ajinomoto Bio-Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
- Engages employees by creating a climate in which they want to do their best.
- Provides oversight and direction to the employees in accordance with Ajinomoto Bio-Pharma Services policies and procedures.
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.