23 days old

QMS Business Analyst

Los Alamitos, CA 90721


Do you want to work
where scientific innovation meets leading-edge technology? Join Accenture
Scientific Informatics Services and help our clients apply digital technologies
to revolutionize scientific and laboratory processes.





Accenture Scientific
Informatics Services combines the scientific and laboratory informatics
expertise of LabAnswer with Accentures strategic and business consulting
capabilities, industry platforms, innovation approach and global scale to help
transform how scientific and laboratory processes are conducted across a
variety of industrieshelping make them faster, more efficient and more
effective than ever before.





Leveraging digital
technologies such as automation, artificial intelligence, Internet of Things,
analytics and cloud, in combination with a fundamental redesign of the
scientific user experience, Accenture Scientific Informatics Services helps
organizations better capture, manage, integrate and analyze complex scientific
data. This can improve the discovery and manufacturing of new products, improve
quality, ensure compliance, reduce time to market and improve operational
efficiency.





As a consultant with Accenture Scientific
Informatics Services you will be exposed to the technologies and processes that
many leading US companies and government agencies utilize. We offer a generous
compensation package consisting of salary, bonuses and benefits.






Under minimal supervision from a more senior
business analyst or project manager:

Understand and Identify business processes and
improvements for Quality Management Systems (QMS) domain in a GMP environment.
In order of importance, prior QMS related experience should include: CAPA,
Change Control, Investigation Management, Document Management, and Training

Identify opportunities for improvement and
efficiencies gained by successfully adopting new QMS solutions (i.e. Veeva, Master
Control, Trackwise, ComplianceWire, SumTotal)


With business stakeholders, implement business
process improvements


Create use cases

Create high-quality user and functional
requirements


Analyze requirements to determine priority and
business value

Conduct meetings, document meeting notes and
distribute meeting notes to invitees

Initiate interviews, site visits and workshop
sessions with business Users one-to-one and in groups.

Create required regulatory and SDLC
documentation

Collect information regarding and monitor
progress of business analysis activities

Create as-is and to-be process maps and narratives

Create requirements traceability matrices

Provide estimates for workstream activities,
including dependencies, to the Project Manager

Identify, manage and resolve risks and issues
related to the workstream

Provide Project Manager with status updates,
activity progress and schedule updates

Maintain excellent client relationships

Review and estimate change requests

Create and maintain SDLC documentation

Contribute to all areas of system
implementation including but not limited to vendor interaction, system
compatibility, change control, qualification, deployment, and training

Work with project teams to ensure compliance
with regulatory requirements such as FDA, CAPA, CLIA, GxP,HL7 as well as
internal policies and processes

Create and deliver training materials to end
users

Collect and monitor progress on project
activities from resources

Determine and document overall workstream
approach

Plan and estimate activities within the
workstream

Provide leadership for all resources within a
specific workstream including client, vendor, consultants and associates

Perform stakeholder identification and
analysis

Determine if defects are valid and disposition
them





Basic Qualifications:


Expert understanding of a single industry

Expert understanding of a single system type within the QMS domain

3+ Years of experience in QMS projects

3+ Years of experience working in regulated environments



Desired Qualifications:



3+ Years of consulting experience

Good understanding of three or more system types and their interrelationships
within the QMS domain


Certified
Business Analysis Professional (CBAP) certification


4 Year
degree in an applicable field

Excellent written and verbal communications skills

Excellent organizational skills








Applicants for
employment in the US must have work authorization that does not now or in the
future require sponsorship of a visa for employment authorization in the United
States and with Accenture (i.e., H1-B visa, F-1 visa (OPT), TN visa or any
other non-immigrant status).



Accenture is an EEO and Affirmative Action Employer of Females / Minorities
/ Veterans / Individuals with Disabilities.



Accenture is committed to providing veteran employment opportunities to our
service men and women.



Equal Employment Opportunity - All employment decisions shall be made without
regard to age, race, creed, color, religion, sex, national origin, ancestry,
disability status, veteran status, sexual orientation, gender identity or
expression, genetic information, marital status, citizenship status or any
other basis as protected by federal, state, or local law.



Candidates who are currently employed by a client of Accenture or an affiliated
Accenture business may not be eligible for consideration.


Categories

Posted: 2019-08-02 Expires: 2019-09-11

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QMS Business Analyst

Accenture
Los Alamitos, CA 90721

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