A Quality Assurance Specialist in Information Technology leads compliance initiatives in support of company policies and Regulatory requirements to support product and internal IT controls related to 21 CFR Part 820 & Part 11, Annex 11, and other health care industry standards/best practices.
IT QA also assists our IT unit to integrate best practice concepts into our processes to increase efficiency and meet compliance requirements and assure our customers receive only the highest quality services.
Day to day responsibilities include:
Support Application teams to facilitate the SDLC process for new Applications & Systems.
Perform Risk Impact Analysis for Infrastructure and Application installations and upgrades.
Provide guidance on Quality System Regulations to define applicable requirements.
Assist Project Managers to define applicable project deliverables and create project plans and reports.
Assist Project Managers to define appropriate levels of governance for individual projects.
Collaborate with teams to develop testing strategies.
Review project deliverables to assure quality system standards and internal procedural requirements are met.
Review and approve test instructions and records in support of validation activities.
Work with IT personnel to improve efficiency of the SDLC/ALM processes and compliance to QSR and ISO standards.
Apply standard CAPA techniques (containment, correction, investigation, corrective action, etc.) to clear issues impeding project completion.
Write, update and/or review IT procedures and work instructions.
Keeps abreast of trends and applications.
Leads smaller projects.
Performs work on several functions/applications.
Bachelor's degree or equivalent in a related life science/technical discipline.
8+ years’ experience in a regulated industry, or equivalent combination of education and experience.
Participation as a Project Manager or an Analyst in an IT Delivery project using a formal SDLC.
Understanding of international standards and regulations (e.g. ISO 13485, 21CFR Part 11, GxP) as they apply to computer systems used in the quality system and for the development and manufacture of Bio-Rad products.
Strong understanding of GMP and quality systems.
Problem solving, decision making, time management, organization, communication, leadership and computer skills.
Able to write clear and concise summaries of complex technical topics.
Proven ability to contribute to the analysis and lead the implementation of solutions to complex IT problems.
Strong cross functional business knowledge. Understands the major business processes of each company function.
Strong interpersonal communication and presentation skills.
Proficient in Microsoft Office software.
Proficiency in HPALM and Service Now beneficial.
Project management experience a plus
About Bio-Rad Laboratories, Inc.
Bio-Rad Laboratories advances scientific discovery and improves healthcare through its unique combination of people, products, and a strong focus on the success of our customers. Our broad range of life science research and diagnostic products are used worldwide by researchers to gain a greater understanding of disease and and by clinical laboratories to provide high-value diagnostic test results. We have developed a solid and well-earned reputation for quality and customer service among university and research institutions, hospitals, public health and commercial laboratories, as well as biotechnology, pharmaceutical, and food safety industries. Bio-Rad complements its customer-centric approach with a stable work environment for its employees to succeed.
Mission: Advance discovery. Improve lives.
These two key objectives are the driving force behind every decision we make, from developing innovative ideas to identifying and implementing solutions that solve some of our customers’ greatest challenges. Our mission strongly reflects the goals of our two global primary customer segments: the life science and clinical diagnostics markets.