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Quality Assurance Specialist II

2 months ago

Cumberland, Rhode Island, United States NEUROTECH U S A Full time
Job Description

About Neurotech Pharmaceuticals

Neurotech Pharmaceuticals is a leading biopharmaceutical company dedicated to developing innovative treatments for retinal disorders. Our cutting-edge technology and commitment to excellence have earned us a reputation as a trusted partner in the industry.

Job Summary

We are seeking a highly skilled Quality Assurance Specialist II to join our team in Cumberland, RI. As a key member of our quality team, you will be responsible for providing oversight to our validation program, ensuring compliance with regulatory requirements, and driving quality improvements across the organization.

Key Responsibilities

  • Validation Program Oversight: Provide expert guidance on validation strategies, documentation review, and quality assessments to ensure compliance with regulatory requirements.
  • Quality Assessments: Conduct regular quality assessments of facilities, personnel, and documentation to identify errors or deficiencies and implement corrective actions.
  • Technical Expertise: Provide technical expertise and guidance on validation approaches and documentation to ensure quality and compliance.
  • Quality Culture Development: Help develop and maintain a quality culture by educating personnel on policies and controls.
  • Deviation Management: Participate in rapid response and provide quality guidance for deviation events.
  • Procedure Review and Approval: Review and approve procedures, training documents, deviations, CAPAs, and change control forms.
  • Root Cause Analysis: Participate in Root Cause Analysis to support deviation investigations of moderate to high complexity.
  • Batch Record Review: Perform quality batch record and documentation review to ensure release of Raw Materials and Product.

Requirements

  • Education and Experience: Bachelor of Science or Engineering with 5-7 years of relevant work experience in the cGMP Biotechnology and Medical Device industry.
  • Knowledge and Skills: Proven ability to articulate and teach quality principles, compromise and understand multiple points of view, and manage multiple tasks and expectations.

What We Offer

Neurotech Pharmaceuticals offers a competitive compensation package, benefits through Blue Cross BlueShield and HealthEquity, a 401(k) through Fidelity with a company-sponsored match, generous vacation time, and company holidays.