QA Area Specialist III - Finished Production (Validation Focus)

Location: Onsite in Clayton, North Carolina, Monday-Friday

Company

hirify.global is a global pharmaceutical and healthcare company developing treatments for diabetes, obesity, and other serious chronic diseases.

What you will do

• Provide quality oversight for finished production, batch release, validation activities, and validated equipment, processes, and systems.
• Review and approve change controls, deviations, CAPAs, SOPs, investigations, risk assessments, and other cGMP documentation.
• Ensure compliance with regulations, ISO standards, corporate procedures, and local quality systems.
• Lead process improvements, self-audits, root-cause analysis, trend reporting, and quality management reviews.
• Support audits and inspections, coach site personnel, and provide quality presence and process confirmation on the shop floor.
• Act as a site process representative and support quality processes across the department.

Requirements

• High school diploma or GED required; a bachelor's degree in life sciences or a related field is preferred, and required for the AQP designation.
• At least seven years of QA or related quality experience in manufacturing, utilities, or packaging systems, preferably in pharmaceuticals or medical devices.
• Prior experience in a GMP environment and at least four years reviewing GMP documents for compliance and approval.
• Experience with quality risk management, risk and vendor assessments, validation, change control, deviations, CAPA, audits, and root-cause analysis.
• Knowledge of 21 CFR Part 11, GAMP5, ISO requirements, data integrity, cGMP documentation, statistical methods, and process controls.
• Ability to move equipment or supplies weighing up to 33 pounds and perform precision work in a manufacturing facility.

Nice to have

• Auditing certification or internal/external auditing experience.
• Expertise in sterilization, packaging, cleaning, utilities, process, laboratory, or computer validation.
• Knowledge of semi-finished manufacturing, finished manufacturing QC, IT, and process utilities.
• Experience with Lean, Six Sigma, and other continuous improvement methodologies.

Culture & Benefits

• Paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an additional company match option.
• Paid parental and family medical leave, life and disability insurance, and tuition assistance.
• Access to hirify.global-marketed pharmaceutical products and employee referral awards.
• Mentorship and development resources within a global manufacturing organization.