Quality Assurance Specialist (cGMP Laboratory)

NxtGen is a growing cGMP analytical testing laboratory specializing in peptide and protein characterization. We are seeking a Quality Assurance Specialist to support and maintain quality systems ensuring compliance with regulatory requirements and data integrity standards.

This role is ideal for candidates with hands-on experience who can operate independently and contribute to data quality, method execution, and laboratory efficiency.

Key Responsibilities

• Review laboratory documentation, including analytical data, reports, and logbooks, for accuracy and compliance
• Ensure compliance with cGMP, GLP, and data integrity (ALCOA+) requirements
• Manage document control processes (SOPs, test methods, forms, revisions)
• Support and track deviations, OOS/OOT, CAPA, and change control activities
• Assist with internal audits and regulatory inspections
• Maintain training records and ensure personnel compliance with training requirements
• Support implementation and continuous improvement of the Quality Management System (QMS)
• Ensure proper documentation practices across laboratory operations
• Collaborate with laboratory staff to resolve compliance and documentation issues

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
• 2–5 years of experience in QA or QC within a GMP-regulated environment
• Familiarity with FDA cGMP (21 CFR 210/211) and 21 CFR Part 11 requirements
• Experience with document control systems and quality systems (QMS)
• Knowledge of laboratory operations (analytical testing, instrumentation) preferred
• Strong attention to detail and organizational skills

Why Join NxtGen

• Be part of building a quality-first culture in a peptide-focused analytical lab
• Work in a collaborative, fast-paced startup environment
• Gain exposure to end-to-end cGMP quality systems and regulatory compliance
• Contribute directly to audit readiness and client confidence

Working Conditions

• Environment: Laboratory setting with exposure to chemicals, biological materials, and laboratory equipment.
• Schedule: Monday – Friday, 7:00 AM – 3:30 PM.
• Location: North Charleston, SC.
• PPE: Required use of personal protective equipment (lab coat, gloves, safety glasses).

Equal Employment Opportunity

• NxtGen is a Disabled and Veteran Equal Employment Opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Benefits

• Competitive salary
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Employee Purchase Program