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Senior Quality Assurance Specialist- QA Validation

3 months ago

Holly Springs, Georgia, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

Sr. QA Specialist- Quality Assurance Validation & Tech Support - Computer System Validation and Data Integrity

Live

What you will do

Let's do this. Let's change the world. In this vital role we are looking for an individual to work alongside with DTI (Digital, Technology and Innovation) to provide QA oversight of the design and technology of the DTI ecosystem at ANC. The focus of the role will be to provide quality oversight in bringing DTI platforms to ANC, be the QA expert on Computer System Validation (CSV) and be the site data integrity SME to work to provide guidance and expertise to the Amgen Quality Network. This role brings forth the opportunity to provide a direct impact on the CSV global network

This role will also have the opportunity to aid in the commissioning & qualification and process qualification of the facility, utilities, and equipment. You will collaborate cross-functionally to ensure project timelines and achievements are met. Once the site is operational, this role will continue to provide site wide validation oversight, with a focus on CSV, as well as quality oversight for all non-manufacturing functions (such as Facilities/Engineering, Supply Chain, Quality Control) and their associated processes, changes, deviations, CAPAs, and capital projects.

  • Be the QA partner on a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and QA oversight.
  • Keep track of industry and technology trends, connect, and cultivate external networking opportunities to deliver valuable insight from other similar professionals in our industry.
  • Support DTI in the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and work together to recommend optimal solution.
  • Effectively maintain relationships with DTI service and system owners, business partners, enterprise DTI service partners, and vendors.
  • Provide QA support for leading DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.
  • Be the site Data Integrity SME while providing guidance and strengthening the Amgen Global Quality Network.
  • Participate in the design of Audit Trail Review of Computer Systems data and enforce to Amgen Standards
  • Participate in Data Integrity (DI) Assessment of Computer Systems, Interfaces, Processes to identify any potential data vulnerabilities in the design of the systems.
  • Ensure that validation deliverables properly test key Data Integrity elements (e.g., audit trails, access levels, backup/restore) previous to system release into the Production environment.
  • Represent ANC QAV & TS at the globalized Computerized System and Data Integrity network meetings.
  • Consult with Network and Global quality groups as required to ensure consistent, compliant, and aligned approach is being implemented.
  • Responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of CSV computer systems validation.
  • Provide quality guidance and support during fulfillment of commissioning and qualification testing, reviewing, and approving changes and discrepancies, as required.
  • Author, own, review and approve controlled documents, including Standard Operating Procedures, Work Instructions, Forms, etc.
  • Provide quality oversight for quality records including change controls, deviations/CAPAs, and work requests ensuring alignment to procedural requirements and confirming assessments and evaluations of different partners are complete and accurate.
  • Ensure that all activities & related documentation for facilities, equipment, materials, computer systems and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
  • Support the Quality Systems Compliance team and site in the fulfillment of the site readiness plan with focus on supporting start-up and ongoing quality oversight of site Computer Systems
  • Lead and support continuous improvement initiatives.
  • In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role.
  • Potential travel up to 25%.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 12 years of Information Systems, Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience OR
  • Associate's degree and 10 years of Information Systems, Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience OR
  • Bachelor's degree and 6 years of Information Systems, Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience OR
  • Master's degree and 4 years of Information Systems, Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience OR
  • Doctorate degree and 2 years of Information Systems, Engineering and/or Information technology experience and/or Quality oversight of computer systems validation experience

Preferred Qualifications:

  • Previous experience in computer system validation (CSV) or quality oversite of CSV.
  • 2+ years' combined experience with the following product platforms: Data Historian (OSI PI), MES (Korber), Delta V Automation platform, and/or laboratory systems and/or IS platforms, highly desired.
  • Experience in change management for the integration/embedment of data integrity into existing systems.
  • Experience with computerized systems including troubleshooting, reliability, and performance improvements.
  • Knowledge of industry standards for systems development life cycle (SDLC) methodologies and 21 CFR Part 11.
  • Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).
  • Ability to work with DTI partners to evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.
  • Experience with reviewing, participating, and leading in Data Integrity and compliance assessments of computer systems and software.
  • Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.
  • Demonstrable understanding of GxP compliance and capability and experience applying GMP requirements in an operational setting.
  • Must be highly organized and capable of working in a team environment with a positive attitude under minimal direction.
  • Demonstrable ability to provide sound quality guidance and make data-driven, risk-based, decisions.
  • Excellent written and verbal communication skills.
  • Ability to work in a team matrix environment and establish relationships with partners.
  • Great attention to detail and high degree of accuracy in task fulfillment and GMP documentation.
  • Ability to provide updates to senior management, identifying potential issues, and following assignments through to completion.
  • Demonstrated ability in problem solving and driving improvement.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.