QA Specialist II - Operations (GMP)

Location: Portsmouth, New Hampshire, United States; onsite in the Portsmouth office. Third shift on a 12-hour rotating schedule from 7:00 PM to 7:00 AM, including rotating Monday–Tuesday and Friday–Sunday workdays.

Company

hirify.global operates globally connected life sciences manufacturing sites that produce medicines and support the development of viable therapies.

What you will do

• Provide daily QA presence in GMP operational areas and review documentation and manufacturing practices.
• Partner with Manufacturing and Operations teams to maintain compliance with GMP standards and internal procedures.
• Guide personnel on GMP behaviors, documentation practices, and routine or non-routine compliance questions.
• Make routine GMP-related decisions, escalate complex compliance risks, and respond to QA Hotline requests.
• Manage equipment quality status, including Quality Tag Outs and equipment release after product changeover.
• Support data integrity, inspection readiness, and compliance-focused cross-functional projects.

Requirements

• Associate or bachelor’s degree in a scientific or engineering discipline, or equivalent relevant experience.
• Basic understanding of cGMP regulations, good documentation practices, manufacturing processes, and quality control activities.
• Awareness of product clearance and line clearance requirements in manufacturing operations.
• Experience following SOPs and completing documentation accurately in a regulated environment.
• Ability to identify unusual events or potential compliance issues, communicate concerns, and escalate appropriately.
• Strong attention to detail, communication, organizational, prioritization, and teamwork skills.

Nice to have

• Scientific or engineering background in Chemistry, Biology, Biochemistry, Chemical Engineering, or a related field.
• Familiarity with SAP, LIMS, TrackWise, Syncade, or similar manufacturing and quality systems.

Culture & Benefits

• Performance-related bonus.
• Medical, dental, and vision insurance.
• 401(k) matching plan.
• Life insurance and short- and long-term disability insurance.
• Employee assistance programs and paid time off.