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Sr. Lab Systems Analyst

Company: Ajinomoto Bio-Pharma
Location: San Diego
Posted on: November 22, 2021

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 looking for an innovative individual to join as a Sr. Labs Systems Analyst. This position supports the development, enhancement, and validation electronic Quality Management System (QMS) applications and related technology (e.g. MasterControl). The Sr. Analyst will collaborate with internal quality groups and manufacturing laboratories, as well as IT to develop and maintain solutions that provide a more efficient and compliant work environment. This role is an internal customer-interfacing position that requires a unique combination of computer systems knowledge and understanding of laboratory operations, specific regulatory requirements set forth by the FDA/EU. Responsibilities:

  • Provide daily technical support to QMS users in a timely fashion.
  • Deliver training to end-users on various system processes.
  • Ensure support tickets are up to date and accurate.
  • Troubleshoot incidents reported by end-users and through system logs and provide effective resolutions.
  • Responsible for performing routine and non-routine operations within laboratory software systems.
  • Assist in the design, development, testing, documentation, and implementation of changes to production software.
  • Assist in the configuration and maintenance of user accounts, analyses, calculations, lists, specifications, and many other core system objects.
  • Consistently follow solution delivery lifecycle, company Standard Operating Procedures (SOP's) and company policies at all times.
  • Seek innovative ways to improve manufacturing and quality productivity via system functionality.
  • Evaluates quality systems deployment and implements process improvements to decrease TAT on OOS, CAPAs, and deviations.
  • Propose, champion, sponsor and/or participate in departmental and cross-functional operational excellence initiatives to facilitate company process improvement efforts.
  • Provide project management support for the implementation of new processes within the electronic QMS.
  • Serve as quality system subject matter expert for clients and regulatory body inspections
  • Develop view, standard queries, custom reports and dashboards based on requirements. Requirements:
    • Bachelor's degree in a Life Sciences discipline or equivalent required.
    • Minimum 2 years of experience in pharmaceutical manufacturing, with a background in Quality Assurance or Software Validation.
    • Minimum two 2 years of experience in electronic Quality Management Systems implementation and management. MasterControl systems is preferred.
    • Electronic QMS integration experience with external systems desirable.
    • Experience with Quality KPIs and electronic reporting from validated databases is required.
    • Experience in management of information systems, including GMPs/GDPs.
    • Experience with electronic batch records is highly preferred.
    • Effective time management through balancing multiple project responsibilities, ad-hoc customer requests, and project-related activities and support.
    • Always focused on the details, and a strong written, verbal communication and presentation skills.
    • Ability to work independently, within prescribed guidelines, or 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
      • 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. Qualified M/F/D/V candidates are encouraged to apply.

Keywords: Ajinomoto Bio-Pharma, San Diego , Sr. Lab Systems Analyst, Healthcare , San Diego, California

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