Business Analyst - 21 CFR Part 11, cGMP, Documentation, Labaratory

Job Description: SMCI is seeking a Validation Engineer Senior to be responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Implement 21 CFR Part 11 for new and existing computerized analytical instruments, perform gap assessments and define resolutions in compliance with cGMP requirements. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.Required Skills: 21 CFR Part 11; cGMP; Documentation; Labaratory. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please)(H1 sponsorship currently unavailable)(Local candidates only, please)