QA Specialist II-Operations (Life Sciences)

TL;DR

QA Specialist II-Operations (Life Sciences): Providing real-time Quality Assurance support for GMP manufacturing operations with an accent on compliance, inspection readiness, and documentation review. Focus on performing floor oversight, reviewing batch records, and ensuring adherence to cGMP regulations in a pharmaceutical environment.

Location: Based in Portsmouth, NH (Onsite, 1st shift, 12-hour rotating schedule)

Company

hirify.global is a global life sciences company with 30+ sites across five continents, dedicated to manufacturing the medicines of tomorrow.

What you will do

• Provide real-time QA support for GMP manufacturing operations to promote compliance and inspection readiness.
• Perform routine floor oversight within GMP areas, reviewing activities and documentation.
• Review batch records, logbooks, and other GMP documentation for accuracy and compliance.
• Coach manufacturing personnel on GMP behaviors, documentation practices, and quality expectations.
• Manage Quality Tag Outs and support equipment clearance and product changeover activities.
• Participate as the Quality representative in cross-functional meetings, investigations, and project teams.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 3–5+ years of experience in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Hands-on experience reviewing batch records and GMP documentation.
• Solid understanding of cGMP regulations, ICH guidelines, Good Documentation Practices (GDP), and data integrity.
• Working knowledge of fermentation, purification, and quality control process steps.
• Experience with quality systems such as TrackWise, SAP, LIMS, or Syncade.

Culture & Benefits

• Performance-related bonus.
• Comprehensive medical, dental, and vision insurance.
• 401(k) matching plan.
• Life, short-term, and long-term disability insurance.
• Paid time off (PTO) and employee assistance programs.