Sr. QA Audit Specialist
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 Sr. QA Audit Specialist to join the team and support audit inspection readiness for Aji Bio-Pharma’s clinical and commercial manufacturing facilities. The candidate will utilize their skills to hosts customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System.
Responsibilities:
- Leads customer audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
- Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Quality Agreements
- Supports the execution of internal audit program
- Supports risk management program
- Supports the continuous improvement of the Quality Management System
- Reviews and approves quality management system standard operating procedures (SOPs)
- Reviews and approves deviation reports and CAPAs related to quality systems
- Generates quality system metrics for management review meetings
- Trains team members on conducting internal and external audits
Requirements:
- Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required.
- Minimum of 6 years of relevant QA experience in a regulated industry.
- Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
- Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
- Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing.
- Detail-oriented with strong organizational 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.