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. Technical Quality Associate II to join our team. Thisposition is responsible for performing a wide variety of technical quality documentation review activities pertaining to assuring compliance with applicable Quality Assurance (QA) and regulatory requirements, including assisting with reviewing Quality Agreements, supporting with impact assessments related to the risk management program as well as reviewing deviations, CAPAs and change controls.
Responsibilities:
Reviews and approves executed technical documentation in support of the manufacture and testing of Drug Substance and Drug products.
Review and compile product impact assessment reports related to the risk management program by obtain data and supporting information from the Subject Matter Experiences (SMEs)
Provide associated data in support of cGMP operations activities.
Extract product related data from client batch records to perform impact assessments
Processes Technical Quality documentation initiation, revisions, and deletions related to the Quality Agreement program.
Assists in the distribution of Technical Quality documents to all appropriate individuals and departments.
Ensures completeness and accuracy of information contained in all documents, document files, databases, and quality systems.
Support the Quality Assurance team with review of technical deviations, CAPAs and change controls
Maintains Technical Documentation files and archives.
Performs Technical Quality review of validation protocols and reports.
Assists with internal, client and regulatory audits.
Assists with the generation of department metrics.
Assists with developing recommendations for continuous improvement projects
Promotes a compliant cGMP environment and follows SOP’s.
Regular and reliable attendance onsite 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.
Requirements:
Bachelor’s degree preferred in a Life Sciences discipline or equivalent work experience.
Minimum four (4) years of relevant experience in documentation review, technical quality, validation, QA or equivalent is required.
Knowledge of cGMP regulations and good documentation practices (GDP) preferred.
Experience working in Manufacturing following cGMP is desired.
Working knowledge of drug development and GMP aseptic processing operations.
Knowledge of cGMP regulations 21CFR Part 11, 210, 211, 600 & EU guidelines.
Detail oriented and strong written and verbal communication skills.
Ability to work independently, within prescribed guidelines, or as a team member.
Demonstrated ability to follow detailed directions in a laboratory environment.
Must be familiar 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.
