QA Specialist III-Operations

Requirements

• Bachelor's degree in scientific discipline or equivalent experience
• 4-6 years of experience in a pharmaceutical, biotechnology, or cGMP-regulated environment
• Strong experience reviewing and approving GMP documentation across operations, validation, engineering, or quality functions
• Solid understanding of cGMP regulations, documentation practices, and quality systems
• Strong attention to detail and analytical skills, with the ability to identify and resolve documentation and compliance issues
• Effective written and verbal communication skills, with the ability to collaborate across cross-functional teams
• Ability to manage multiple priorities and work independently while meeting deadlines
• Customer-focused mindset with the ability to provide clear guidance and escalate issues as appropriate
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Benefits

Additional Information

QA Specialist III-Operations Location: This position is based in our Portsmouth, NH office. The typical work schedule is Monday through Friday, 8:00 AM-4:30 PM EST. What you will get: Below you will find a comprehensive summary of the benefits package we offer: Performance-related bonus. Medical, dental and vision insurance. 401(k) matching plan. Life insurance, as well as short-term and long-term disability insurance. Employee assistance programs. Paid time off (PTO). Compensation for this role will be determined by the candidate's qualifications, skills, experience, and relevant knowledge. What will you do: We are seeking a detail-oriented QA Specialist III, Operations to support document review and quality oversight activities within a cGMP manufacturing environment. This role is responsible for reviewing and approving GMP documentation, ensuring compliance with internal procedures and regulatory requirements, and supporting cross-functional teams to maintain high-quality standards. The ideal candidate will bring strong technical writing and review experience, a solid understanding of quality systems, and the ability to work independently while collaborating effectively across the organization. Independently review and approve GMP documentation, including SOPs, work instructions, forms, and electronic batch records within the document management system Review and approve validation and qualification documentation, including protocols and summary reports for equipment, instrumentation, and computer systems Review non-DMS documentation such as maintenance records, engineering documentation, and supporting quality records to ensure compliance Provide detailed feedback and recommendations during document review to ensure accuracy, completeness, and adherence to procedures Ensure document changes are appropriately justified, documented, and aligned with revision control processes Serve as a subject matter resource for document review related to validation, equipment, and analytical systems Collaborate with QA, Manufacturing, Engineering, and other stakeholders to resolve documentation and quality issues Support continuous improvement efforts to enhance documentation practices, compliance, and overall quality systems

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