Sr. QA Data Integrity and Risk Management - Remote
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 Sr. QA Compliance Associate I -Data Integrity & Risk Management who will utilize their analytical and problem-solving skills to facilitate and complete risk management plans, implement and ensure compliance to data integrity policies, and support other key Quality Assurance programs. This role is a great fit for a candidate who is both personable and highly knowledgeable in risk management concepts.

*This position is an exciting remote opportunity, associates will need to work PST.

Responsibilities

  • Leads to identify, analyze, and evaluate risk management plans following Quality Risk Management process per ICH Q9, collaborates with Subject Matter Experts (SME) for technical input, maintain the Risk Register, and tracks deliverables to closure
  • Leads implementation and improvement of the Data Integrity Program as the Data Integrity Officer, ensures compliance to the Data Integrity Plan
  • Facilitate meetings with Subject Matter Experts to mediate and resolve conflicts related to Data Integrity and process/product risks
  • Support other key QA programs (e.g. deviations, CAPAs, etc) as related to data integrity and risk management
  • Reviews and approves quality management system standard operating procedures (SOPs) as related to data integrity and risk management
  • Participates in customer and regulatory audits as SME for topics related to this position's responsibilities
  • Generates and presents Risk Management and Data Integrity metrics for management review meetings
  • Train team members on risk management concepts and data integrity principles
  • 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 discipline or equivalent relevant experience required.
  • Minimum of 6 years of relevant experience in a regulated industry.
  • Advanced-level understanding of regulatory guidances and requirements related to Risk Management and Data Integrity
  • Knowledge and hands on experience with risk assessment tools such as FMEA, gap assessments, what-if analyses, etc.
  • Highly effective in cross-function collaboration, leading improvement projects, and training team members on risk management and data integrity concepts
  • 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
  • Employee Appreciation Events
  • Employee Discount Programs
  • Tuition Reimbursement
  • Casual Dress Code
  • Wellness Programs
  • Community Outreach Opportunities

Minimum full-time salary range between $45.00 - $55.00 per hour + bonus + benefits.

Aji Bio-Pharma considers a range of factors, including background and experience as well as geographical location, when determining compensation. These considerations means actual compensation will vary.

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
6+ years
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