US-MA-Cambridge: Lead QA Specialist
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682539_Lead_QA_Specialist_.html
To see other op****tunities, please visit http://sqa.fyicenter.com
Date: 10-Jun-2008
Lead QA Specialist
Key Responsibilities:
The individual will serve as an IS Quality/Validation subject matter
expert (SME) and provide guidance on validation and testing strategies
for each implementation project based on system risk, complexity, and
other relevant factors. This includes, but is not limited to:
* Represent IS Quality/Validation on projects; and management teams as
appropriate * Leader****p on validation strategies for system
implementations and changes to ensure solutions are demonstrated as
fit for purpose * Partner with the Vertex system implementation teams
to ensure Part 11 compliance * Provide consultation and sup****t as
required to meet project goals and objectives. * Perform Quality
review and sign-off of computer system control do***ents * Review
requirements packages and provide compliance & quality inputs to the
requirements engineering process * Manage multiple simultaneous
validation, revalidation, and change control activities. * Provide
compliance/validation leader****p to project teams and validation
contractors * Review and approve validation and test protocols for
adequacy and completeness. * Proactively identify op****tunities for
process improvement in the Systems Life Cycle * Author and/or
contribute to the development and implementation of Vertex Policies,
SOPs, Work Instructions, Forms, and Templates surrounding the Vertex
Systems Life Cycle for on-boarding and validating computer systems
subject to 21 CFR Part 11. * Independently solve Systems Life Cycle
related problems and implements corrective actions as needed * Work to
maintain the validated state of Vertex computer systems by
participating in the change control process * Maintain validation
related metrics and re****ts performance to management * Participate in
and/or sup****t regulatory inspections as assigned * Participate in and/
or sup****t software vendor audits as assigned * May supervise other IS
Quality/Validation staff * Perform other duties as assigned
Requirements Minimal Requirements
* This position requires a B.S. (or equivalent degree) and 8+ years of
relevant work experience as well as a practical working knowledge of
validation, quality assurance, information systems, and risk
management best practices. * Knowledge of GCP, GLP, cGMP, HIPPA
regulations is required with an emphasis on 21CFR Part 11. *
Experience with System Life Cycle models (Waterfall, Rapid Application
Development, Spiral Model, etc.) is needed. * Excellent communication,
interpersonal skills, and customer focus are also essential. * At
least 5 years of direct experience writing and executing validation
do***entation required * At least 2 years of project management
experience in the pharmaceutical/biopharmaceutical industry preferred
* Experience with validating electronic records management, quality,
and supply chain (ERP) systems preferred * Must be able to demonstrate
good communication skills both oral and written * Must be able to
demonstrate excellent customer service skills * Must have demonstrable
flexible & out of the box thinking approach to problem solving and
process improvement * Must be well organized and willing to work as
part of a team * Test automation experience a plus * Knowledge of the
application of ITIL good practices for IT Service Management
preferred
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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