LabWare LIMS Validation Lead 9/3/2016

LabAnswer Phoenixville, PA

Company
LabAnswer
Job Classification
Full Time
Company Ref #
29546067
AJE Ref #
576086882
Location
Phoenixville, PA
Job Type
Regular

JOB DESCRIPTION

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LabAnswer is the leading laboratory informatics consultancy in North America. We work with "best in breed" Laboratory Informatics software products to provide total solutions for our clients. LabAnswer is expert in architecting, configuring, deploying, validating and supporting laboratory systems. These systems include LIMS, ELN, SDMS, and CDS, among others. This domain where laboratory science intersects with information technology is our passion, and unlike some other companies providing similar services, it is our singular focus!

As a LabAnswer 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.

JOB DESCRIPTION:

The candidate will be responsible for Leading a small team in writing and modifying test scripts, as well as dry run execution in LabWare LIMS.

The candidate should have LabWare LIMS, Test Script Writing and Execution, Status reporting experience.

* 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...)

MINIMUM QUALIFICATIONS:

* 4Year degree in an applicable field
* Excellent written and verbal communications skills
* Excellent organizational skills
* 3-5Years of experience working in regulated environments
* 3-5Years of experience in Laboratory Informatics projects
* 3-5Years of experience in testing and validation

DESIRED QUALIFICATIONS:

* SME on SDLC, GxP and Compliance regulations
* 1-3years of consulting experience

We offer comprehensive benefits to regular full-time employees including but not limited to:

* Unlimited ceiling for professional growth opportunities within LabAnswer
* You will also have opportunities to take advantage of training programs to advance your career; our extensive online library includes a assortment of technical and professional training tools and resources
* Opportunities to work across a variety of industries (Pharmaceutical, Medical Device, Consumer Products, Energy, Environmental, Forensics, Genomics, Government etc.)
* Opportunities to work across a variety of laboratory environments (analytical testing, biotech, clinical trials, forensics, medical device, pharmaceutical, public health and research hospitals)

* Comprehensive health and welfare programs to fit your individual or family's needs:

* Health Insurance
* Dental Insurance
* Vision Insurance,
* 401(k) Retirement Saving that includes a generous employer match
* Paid Time Off (vacation, sick, holiday)
* Company Paid Life Insurance
* Company Paid Short and Long Term Disability Insurance
* Wellness Plans and Rewards

* Strong company values of team work, culture and values, personal and professional development, work-life balance, and recognition
* Competitive compensation with opportunities to participate in employee bonus plan and travel bonus plan