QA Compliance Specialist - LSA (Pharmaceutical Quality)

Location: Onsite at the Portsmouth, NH office, Monday through Friday, 7:00 AM–4:00 PM EST

Company

hirify.global manufactures medicines and supports life sciences customers through globally connected teams across more than 30 sites.

What you will do

• Support quality systems activities, including deviations, CAPAs, change controls, investigations, and quality risk management.
• Review quality records and documentation for compliance with GMP requirements, site procedures, and regulatory expectations.
• Prepare for regulatory inspections, customer audits, and internal audits.
• Track, trend, and report quality metrics, KPIs, and compliance indicators.
• Collaborate with Manufacturing, Quality Control, Validation, Engineering, and other functions to address compliance gaps and implement corrective and preventive actions.
• Provide GMP guidance, manage SOPs and quality documentation, and support training and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences, Chemistry, Biology, Engineering, or a related scientific discipline is preferred.
• At least 3 years of experience in Quality Assurance, Compliance, Quality Systems, or a related role in a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.
• Working knowledge of cGMP regulations, FDA requirements, and applicable ICH guidelines.
• Experience with deviations, CAPAs, change controls, investigations, quality systems, regulatory inspections, and audits.
• Strong analytical, organizational, problem-solving, written, and verbal communication skills, with careful attention to detail and compliance.
• Ability to multitask and prioritize work in a dynamic, fast-paced greenfield environment.

Nice to have

• Experience with electronic Quality Management Systems such as TrackWise, Veeva, MasterControl, or similar platforms.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance and short-term and long-term disability insurance.
• Employee assistance programs and paid time off.
• Collaborative culture focused on accountability, excellence, passion, integrity, and continuous improvement.