Senior Specialist Quality Assurance - Validation and Tech Support
Location: Holly Springs, NC
Responsibilities
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 adhere 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 driven.
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 execution 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 execution 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 30%.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The ambitious professional we seek is a resourceful collaborator 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.
Strong knowledge of GxP compliance
Must be highly organized and capable of working in a team environment with a positive attitude under minimal supervision.
Proven 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 build relationships with partners.
Great attention to detail and high degree of accuracy in task execution 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.
Proven capability and experience applying GMP requirements in an operational setting.
Ability to independently interact with various levels and is a self-starter.