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Consultant, Biopharmaceutical, ELN Business Analyst

Company: GForce Life Sciences
Location: San Rafael
Posted on: March 27, 2020

Job Description:

Consultant, Biopharmaceutical, ELN Business Analyst Summary GForce Life Sciences' mission is to make an impact, one person at a time. We do this by assisting our clients, consultants, colleagues, charities, and clinical space. As one of America's Fastest-Growing Private Companies (#8 in 2018 and #90 in 2019; identified by the Inc. 5000 rankings) as well as a repeat Best Company to Work For (Staffing Industry Analysts), our primary focus is matching highly targeted consultants to executives' needs in the medical device, pharmaceutical, and biotech industries. Headquartered in Chicago with a presence in Boston, San Francisco, Florida, and twenty other states, GForce has successfully been engaged in hundreds of engagements in many countries for clients ranging from Fortune 500 to startups.We consider our consultant employees to be the most important piece of the puzzle in this extremely competitive environment. Combine that with our deep client relationships, and attention to detail and we feel strongly that this provides us with a strong advantage in the life sciences consulting industry. Duties / Expectations of Role Support ongoing projects (SDMS, SMP upgrade) in coordination with a manager or Sr. Business Analyst. Perform drafting of project implementation plans, requirement specifications, and execution of test scripts for system validation implementation projects according to applicable GLP and 21CFR11 compliance regulations. Assume Business Process Owner and Subject Matter Expert roles for system validation implementation projects. Prepare controlled documents, process documents, and data reports including but not limited to SOPs, System Design Documents, System Configuration Documents. Perform and assist with tasks for implementation and/or validation of new instrument and computer systems, software, and upgrades. Business Process expert for assigned systems. Collaborate with BAS Managers and Scientists to develop workflow processes in assigned systems. Collaborate with BAS Managers to develop management metrics derived from computer system usage. Provide general Training on computer systems at go live. Ensure data integrity and regulatory compliance is met with SOPs and system configuration. Participate in internal and external inspections and audits. Other reasonable duties as assigned. -- Mandatory Requirements 4+ years of experience as a Network or Laboratory Information Systems (LIMS, ELN, LES, etc.) Administrator. Excellent writing and verbal communication skills. 2+ years authoring SOPs or other technical documents 2+ years gathering requirements from laboratory or scientific staff and translating into URS/FRS or similar 2+ years of computer system validation (CSV) including test script authoring, review or execution. 2+ years of experience working in a bioanalytical laboratory or 2 years working in a biopharmaceutical company. Experience with Good Documentation Practices (GDP). -- Preferred Requirements: Bachelor's degree in computer sciences or life sciences with equivalent experience with management information systems, laboratory information systems; or similar integrated, networked computerized systems; or Clinical Laboratory Scientist with laboratory information systems administrator experiences. Master's degree in computer sciences -- Term & Start 6-12+ month contract. This is a full-time contract role. On-site in the North Bay area.

Keywords: GForce Life Sciences, San Rafael , Consultant, Biopharmaceutical, ELN Business Analyst, Professions , San Rafael, California

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