Posted in Other 30+ days ago.
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Type: Full Time
Location: Hercules, California
# of Openings
Bio-Rad is looking for a Business Systems Analyst, Senior Staff.
* 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 Past 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.
Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.