Quality System Manager
San Diego, CA 
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Posted 26 days ago
Job Description

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 Quality System Manager who supports the maintenance and implementation of electronic Quality Management Systems (QMS) applications and related technology. This position is responsible for the management of the electronic QMS involving the analysis, design, configuration, integration, and maintenance of the systems and any interfaces with other corporate enterprise systems. The QMS Administrator is an internal customer-interfacing position that requires a unique combination of; depth of knowledge of current QMS workflows (i.e., quality event tracking and trending, deviations, CAPAs, change controls, OOS, and document revisions), computer systems knowledge, understanding of laboratory operations, and regulatory requirements set forth by the FDA/EU/ICH for QMS. The position requires interactions and management of projects between all GMP departments. This person is also responsible for developing and maintaining key relationships with software providers for troubleshooting and system improvement/upgrade activities.

Responsibilities:

  • Provide quality, timely and accurate analysis, design, configuration, and support; including daily technical support to end users.
  • Configure process flows for development, testing, and production environments in accordance with approved protocols and scripts.
  • Provide project management for the implementation of new and/or revised processes within the electronic QMS.
  • Maintain and schedule regular system improvements/upgrades while eliminating system downtime.
  • Integrates electronic QMS with external systems using application tools and custom programming of additional functionality, as required.
  • Develop view, standard queries, custom reports, and dashboards based on requirements.
  • Conducts functional testing of client configurations/customizations.
  • Creates and maintains electronic QMS documentation including Administration and User SOP's, functional specifications/user roles, and training materials.
  • Provide system training to end users.
  • 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 Aji Bio-Pharma's cultural values and aligns daily actions with department goals and company culture.

Requirements :

  • Bachelor's degree in a Life Sciences or Engineering discipline or equivalent is required.
  • Minimum of five (5) years of experience in pharmaceutical or medical device manufacturing, with a background in Quality Assurance or Software Validation.
  • Minimum three (3) years of experience in electronic Quality Management Systems use, implementation, and management.
  • Electronic QMS integration experience with external systems is desirable.
  • Regulatory or general audit experience defending QMS is desired.
  • Experience with Quality KPIs and electronic reporting from validated databases is required.
  • Experience in management of information systems, including Data Integrity/GMPs/GDPs.
  • Effective time management through balancing multiple project responsibilities, ad-hoc customer requests, and project-related activities and support.
  • Detail-oriented and strong written, and verbal communication, and presentation skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • 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
  • Employee Appreciation Events
  • 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.

Please be advised that Aji Bio-Pharma follows a comprehensive set of recruiting protocols and conducts interviews either in person or phone/via live video only. We will never use apps like RingCentral or other chat features to conduct an interview. The scammer is using an email account that looks like an Ajinomoto account but ending in .work in an attempt to fool individuals. We strongly recommend ignoring any request that looks suspicious or is unexpected. DO NOT CLICK ON ANY LINKS or provide any information in response to these scams. Please contact us at with any questions.

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"We are an EOE dedicated to a diverse work force and Drug Free work environment. Qualified M/F/D/V candidates are encouraged to apply."


 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
5 years
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