We are seeking an experienced Quality Assurance Validation Specialist to support quality assurance efforts for our client’s capital projects on a contract basis. In this role, you will focus on validation and change control documentation for engineering initiatives related to the client's site products. The individual will ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMPs, etc.

Responsibilities

Change Controls

• Review and preapproval of all Change Controls and impact assessments.
• Review and approval of action items, conditions for release, and summary actions.

Pre-Execution

• Review and pre-approval of protocols.

Execution

• Review and approval of deviations.
• Review and approval of executed protocols and data.

Post-Execution

• Review and approval of summary reports.

General Project Requirements

• Attend weekly and ad-hoc meetings related to the projects.

Qualifications

• Bachelor's degree in Engineering or Life Sciences.
• 5 years of validation / QA experience in a GMP environment.
• Experience with change control as a QA approver.
• Ability to work in a fast-paced environment to meet project timelines.
• Ability to read, understand, and abide by company procedures.

Location

• Andover, MA

Employment Type

• W2 Employee with Ventura Solutions
• 12 month contract

Benefits

• Choice of medical, dental, and vision plans.
• Paid vacation time.
• Competitive hourly rate.
• 401(k)

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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