- Responsible for planning and implementing improvements to existing quality systems.
- Responsible for quality computer system administration, providing technical/end user support for quality computer system, and maintaining close communication with management to keep stakeholders apprised of quality computer system incidents/ resolutions, project validation status, and other relevant issues. The role requires leading and/or assisting in quality computer system validation efforts and ensuring all work is carried out in compliance with cGMPs, company policies and procedures, 21 CFR Part 11, EU Annex 11, ICH guidelines, and other applicable industry regulations.
- Perform administrative duties for quality computer systems, document and troubleshoot system issues, and provide technical and end user support to ensure efficient and trouble-free operation of quality computer systems; work independently or with others to support quality computer systems
- Execute assigned investigation tasks, change control activities, gap assessments, CAPA deliverables.
- Self-manage project work from inception to deployment, including the configuration, validation, and implementation activities for new or upgraded quality computer systems; draft, execute, and review qualification protocols; analyze data and results to verify that acceptance criteria for validation protocols are met. Gather and record all data and information in accordance with cGMP requirements. Maintain inventory and configuration documentation on hardware and software.
- Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from management, end users and clients, and provide status updates on a frequent basis. Maintain a strong working relationship with other departments (direct customers).
- Develop and maintain a current understanding of FDA and European Union regulations as they pertain to computer system validation and compliance.
- Assist with client and regulatory audits
- Able to react to change productively and handle other essential tasks as assigned.
- QMS software troubleshooting and routine global end-user support
- Coordinate and execute required QMS software enhancement packages (twice per year), including validation activities
- Test Script development and execution, with future focus on automation
- Bachelor’s degree (or Associate Degree and additional related work experience) in pharmaceutical science, biology, chemistry, or related science/IT.
- Requires working knowledge of FDA and/or EMEA regulatory requirements/guidelines as they relate to all aspects of quality systems and compliance (i.e., 21CFR Part 11, Data Integrity, etc.)
- Ability to translate customer design requests into finished product, exceeding request expectation (from initial design, user acceptance, testing, deployment, through post deployment support)
- Proficient at debugging own code and existing code
- Continuous improvement focused
- Ability to work with minimal direction
- Detail oriented
- Skills in:
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.