Sr Quality Assurance Specialist

Location: Wilson, NC, United States

Salary: $73,614–$103,528 per year

Company

hirify.global USA operates a pharmaceutical manufacturing plant with chemistry, microbiology, metrology, technology transfer, and laboratory systems functions.

What you will do

• Provide quality oversight for technology transfer, chemistry, microbiology, QC metrology, and laboratory activities.
• Review and approve protocols, investigative studies, raw data, reports, batch records, deviations, OOS/OOT events, and change controls.
• Support process, cleaning, method, filter, and equipment validation activities, as well as stability and component release programs.
• Perform audit trail reviews for analytical equipment and audit laboratory networks for cGMP compliance.
• Administer the site-specific Empower network and provide technical support for laboratory computer hardware, software, and users.
• Create and maintain procedures and system documentation while reviewing operational systems and software upgrades for quality and compliance.

Requirements

• Experience providing quality oversight in regulated laboratory and manufacturing environments.
• Knowledge of cGMP compliance, validation, metrology, laboratory systems, deviations, OOS/OOT investigations, and change controls.
• Ability to review and approve technical protocols, reports, batch records, and investigative documentation.
• Ability to support laboratory computer systems, networks, hardware, and software, including the Empower network.
• Work at the Wilson, NC plant is required.

Culture & Benefits

• Full-time employment with comprehensive medical, prescription drug, dental, and vision coverage.
• 401(k) plan with company contributions.
• Paid vacation, holidays, and personal days.
• Life insurance, disability coverage, employee assistance, and wellness programs.
• Employment is at-will in accordance with applicable federal and state laws.