Senior QA Specialist - Operations

Responsibilities

• Perform independent review and closure of manufacturing batch records and associated documentation to support product release
• Identify and assess discrepancies, non-conformances, and documentation issues, ensuring appropriate resolution in accordance with GMP requirements
• Participate in lot release meetings and coordinate documentation readiness to meet release timelines
• Apply knowledge of manufacturing processes and quality systems to support investigation and resolution of complex issues
• Guide and support junior QA staff on documentation review priorities and decision-making
• Ensure all deviations and quality events are appropriately documented, investigated, and closed
• Apply data integrity principles in all aspects of work, ensuring compliance with regulatory and company standards
• Contribute to continuous improvement initiatives and support daily quality operations as needed

Requirements

• Bachelor's degree in a life sciences discipline or equivalent experience
• 5-10 years of experience in a cGMP-regulated environment within biotechnology or pharmaceutical manufacturing
• Strong understanding of GMP regulations (e.g., ICH, FDA) and good documentation practices
• Experience reviewing batch records, lot release documentation, and quality systems processes
• Familiarity with systems such as TrackWise, SAP, or similar quality management systems preferred
• Strong attention to detail and critical thinking skills, with the ability to identify and resolve issues effectively
• Excellent written and verbal communication skills, with the ability to clearly present information and collaborate across teams
• Ability to manage multiple priorities, adapt to changing workloads, and escalate issues appropriately when needed
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Benefits

Additional Information

Senior QA Specialist - Operations Location: This position is based in our Portsmouth , NH office. The standard schedule is a 10-hour first shift, Wednesday through Saturday, with working hours from 7:00 AM to 5:30 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.

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Company Intel

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