Position Description

MQA Associate I
Location San Diego, CA
Department Quality/Regulatory - 750
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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 multiple MQA Associate I teammates to join on both 1st and 2nd shift! In this role, you will provide QA oversight and support during manufacturing operations. The Associate I performs documentation review and ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.  The Associate I promotes a cGMP environment and collaborates with internal team members to ensure compliance to specifications, processes, and procedures.

 

Please note: 1st shift hours will generally start between 5:00 am – 9:00am and will be an 8 hour shift. 2nd shift hours will generally be 3:00 – 11:30 pm. When applying please indicate if you have are open to be considered for either shift or if you have only a specific shift availability.

 

Responsibilities:

  • Performs cGMP documentation/data review in support of manufacturing operations (e.g. logbooks, cleaning logs, sterilization records, stability reports, buffer batch records, etc.).
  • Performs AQL inspection of final filled product.
  • Performs area line clearance operations in support of manufacturing operations.
  • Provides QA oversight and performs real time, on-the-floor documentation review during manufacturing operations.
  • Acts as backup to generate labels for cGMP use.
  • Reviews, approves, and reconciles labels for cGMP use.
  • Sterile gown qualified to support cGMP activities in sterile suites.
  • Embodies Ai Bio-Pharma’s cultural values and aligns daily actions with department goals and company culture.

 

Requirements:

  • High School Diploma required. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent experience.
  • Zero to two (0-2) years of relevant experience in documentation, QA or equivalent.
  • Knowledge of cGMP regulations and good documentation practices preferred.
  • Demonstrated ability to follow detailed directions in a laboratory environment preferred.
  • Ability to work independently, within prescribed guidelines, and as a team member

 

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.

 

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