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Business Systems Analyst

Company: Planet Pharma
Location: Novato
Posted on: November 18, 2021

Job Description:

Summary

The Business Systems Analyst 2 in the Information Management department at Client will provide application support and implement software that meets the URS and long-term goals/strategy of the QC department. The Business Systems Analyst 2 will help ensure systems are implemented efficiently following a standard process so that the QC lab is delivered systems that enhance compliance, improve efficiency and reduce regulatory risk.

Responsibilities
Gather software specific requirements and draft SDLC documents
Organize project meetings, and perform standard meeting organizer duties (agenda, minutes action items etc.)
Research system/software functionality to determine suitability and its capability of meeting URS
Drive the team towards improved technical solutions to ensure data integrity
Configure software using COTS and GUI to meet specific lab process requirements
Communicate to System Owner and Users how the software meets their requirements
Assist in the development of Risk Assessments by providing software/system specific expertise
Draft preliminary test scripts for IQ/OQ/PQ protocols
Draft SOPs, WIs and other training materials
Document, and communicate project outcomes (Positive/Negative) to management and participate in effort to continually improve process.
Assist in ad hoc projects as needed to address deviation investigations or initiatives.
Provide Post-Go live system/application support

Must Have

SKILLS/EXPERIENCE
Ability to plan and prioritize assignments effectively to meet timeline commitments
A strong desire to implement solutions that solve pressing compliance and process problems
5 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare
Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution
Self-motivation, and be a quick learner of business processes and technology

Highly Desired
Experience implementing, or managing common software solutions used in the QC lab (Empower, SoftMax Pro, LIMS, ELN, LES, etc)
Experience as a software business administrator
2 years bench level laboratory experience
4 years direct experience implementing/validating software in a regulated environment
Experience as a Project Manager or Project coordinator
Experience in generating SDLC deliverables particularly URS, FRS and Config Spec
Experience authoring Test Scripts for IQ/OQ/PQ
Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA)
Experience in standard software development methodologies (Rapid, Waterfall, etc.)
Experience initiating and managing Change Control, and Deviations requests

EDUCATION
Minimum: BA/BS degree in either Lifesciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees - Or a minimum of 4 years direct experience in a similar role with escalating levels of responsibility will be considered
Highly Desired: ASQ, PMI, ITIL certifications, ISO experience, GxP experience

Requirements: Skills: Must Have: * Ability to plan and prioritize assignments effectively to meet timeline commitments * A strong desire to implement solutions that solve pressing compliance and process problems * 5 years in a regulated industry (preferably Pharmaceutical/Biotech, Medical Devices or Healthcare * Strong interpersonal communication skills including, formal presentations, meeting management, negotiation/persuasion and conflict resolution * Self-motivation, and be a quick learner of business processes and technology Highly Desired: * Experience implementing, or managing common software solutions used in the QC lab (Empower, SoftMax Pro, LIMS, ELN, LES, etc) * Experience as a software business administrator * 2 years bench level laboratory experience * 4 years direct experience implementing/validating software in a regulated environment * Experience as a Project Manager or Project coordinator * Experience in generating SDLC deliverables particularly URS, FRS and Config Spec * Experience authoring Test Scripts for IQ/OQ/PQ * Experience/Knowledge of good requirements gathering techniques including process mapping techniques. (LEAN, SIX SIGMA) * Experience in standard software development methodologies (Rapid, Waterfall, etc.) * Experience initiating and managing Change Control, and Deviations requests Education: Minimum: BA/BS degree in either Lifesciences (Microbiology, Biology, Biochem, Analytical Chemistry etc.) or Computer Science/MIS related degrees - Or a minimum of 4 years direct experience in a similar role with escalating levels of responsibility will be considered * Highly Desired: ASQ, PMI, ITIL certifications, ISO experience, GxP experience
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Keywords: Planet Pharma, Novato , Business Systems Analyst, Professions , Novato, California

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