Job Details

Payrate: $54.00 - $57.50/hr.

Summary
Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guidelinecompliance experience. No specific degree requirement - candidates with extensive Computer Systems Validation experience are acceptable regardless of their degree field. Strong communication skills (written and verbal). A team player who can collaborate effectively. Ability to handle escalations professionally and de-escalate conflicts. Must be proactive and engaged, rather than just following procedures passively.

Responsibilities:

• Act as Quality Assurance (QA) contract 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 Supplier Evaluations as needed
• Support project initiatives, process improvements and our 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

Requirements:

• Master's degree in technical or related subjects and 3 years with direct experience
• Bachelor's degree in technical or related subjects and 5 years with direct experience
• Will consider those that have significant years of direct experience in lieu of education requirements
• Act as Quality Assurance (QA) contract 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

Skills:

• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and 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 effectively interacting 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

Pay Transparency: The typical base pay for this role across the U.S. is: $54.00 - $57.50 /hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, denmatch, lifeion benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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