Job Description

Target PR Range: 36-46/hr
*Depending on experience

Duties:
• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review/Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required
Skills & Behaviors:
• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
• Strong organizational skills, including ability to follow assignments through completion.
• Initiate and lead cross functional teams as needed
• Collaborate and communicate with higher level outside resources.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and to effectively interact with various levels of management
• Ability to lead and influence staff outside QA organization
• Able to manage performance issues and conflict
• Ability to evaluate documentation/ operations according to company and regulatory guidelines
• Ability to interpret and apply GMP, GLP, GCP, GPvP regulations
Preferred Qualification
• 5+ years’ experience in a regulated industries in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
• Demonstrated strong Knowledge of industry and business principles
• Demonstrated strong problem-solving abilities and strong risk assessment capabilities

Education:
• Master’s degree in technical or related subject and 3 years with directly experience
• Bachelor’s degree in technical or related subject and 5 years with directly experience
• Will consider those that have significant years of direct experience in lieu of education requirements

Org Unit: GxP Computer Systems Quality Assurance 13228

*CO/NYC candidates might not be considered

Job Tags

Remote job, Contract work,

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