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Employment Type:
Full time
Job Category:
Health Care Provider
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confidential | Anaheim, California
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Job Description

LVGMP LLC seeks a Computer Systems Analyst to manage software implementation and analysis projects for pharm/biotech mfg. Create/update technical documentation including user business requirements, functional specifications utilizing flow-charting & programming logic/specs & validation scripts. Execute validation. Conduct programming assignments with Oracle, Access, & SQL databases to generate & analyze data. Manage & supervise quality control teams to ensure successful delivery & roll-out of software that meets technical business and regulatory requirements. Evaluate software applications & SOPs related to use of software application to ensure clients are following 21 CFR part 11, FDA's data integrity guidelines, ISO 9000, ICH, USP <1115>, USP <1116>, cGMP and GAMP. Min req: Bachelor's in Computer Sci with concentration in information systems, or its equivalent. 5 years exp in computer software applications or similar position required. Exp with computer software applications in the life sciences industry required. Must have demonstrable ability & knowledge in: Java, C++, Access, SQL, Oracle, GxP, cGMP, GAMP, HTML, PHP, Visual Basic, ISO 9000, ICH, GDPR, Annex 11, FDA Data Integrity Guidelines, FDA 21 CFR part 11 electronic signatures. Intermittent travel to client sites required. Place of employment: 730 Arizona, Suite 427, Santa Monica, CA 90401. Hours: 9am 5pm, M-F. Send resume & cover letter to: Parsa Famili at support@lvgmp.com
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