7 days old
2018-06-122018-07-14

LIMS Validation Specialist

Wilmington, DE 19806
Title: LIMS Validation Specialist
Location: USA
Job Number: 00536012

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 an Accenture Scientific Informatics Services consultant 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.





Create and Modify Validation Documentation Including but not limited to:



Req Specs.



IQ/OQ



Validation Analysis



Validation Plan



Validation Report



Validation Protocol



Technical Design Spec



Security Configuration



Business Impact Assessment



Business Process Analysis



Risk Assessment



Service Level Agreement



Statement of Work



Change Control



SOPs



Traceability Matrix



Write and execute test scripts



Report defects identified during test script execution



Participate in status meetings



Contribute to status reporting



Identify issues and communicate to appropriate level of authority



Participate in identification of validation risks



Communicate with Test Manager and/or PM accordingly



Create and distribute internal status reports



Create client facing status reports



Perform quality checks on peer documentation



Participates in the development of the Validation and Testing Strategy



Distributes client facing status reports



Lead validation status meetings



Lead, plan and manage test script execution



Responsible for defect review/management



Responsible for quality review of client facing status reports



Responsible for quality checks on documentation prior to delivery to client



Lead activities to identify validation risks



Responsible for Issue remediation



Communicate status, risks, and metrics as needed to Project Management



Responsible for the data aggregation of KPIs



Guide project teams to follow GDPs as well as to ensure quality processes are followed in all aspects of the project (development, configuration, data management, business analysis, etc...)


Qualifications:


Minimum Qualifications:






+ 4 Year degree in an applicable field

+ 3 Years of experience working in regulated environments

+ 3 Years of experience in Laboratory Informatics projects

+ 3 Years of experience in testing and validation





Desired Qualifications:






+ SME on SDLC, GxP and Compliance regulations

+ 1 year of consulting experience

+ 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).




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


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


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.


Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.


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
















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LIMS Validation Specialist

Accenture
Wilmington, DE 19806

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Accenture
Wilmington, DE
US

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