Quality Assurance Specialist II - GCP

Location: Union, New Jersey, USA; onsite full-time

Salary: USD 65,000–80,000 per year

Company

hirify.global is a global testing, inspection, and certification company focused on sustainability, quality, and integrity, with a network of offices and laboratories worldwide.

What you will do

• Support the standardization, harmonization, and continuous improvement of the quality management system.
• Oversee clinical studies involving human subjects at the Union site and support studies at other North American locations.
• Conduct real-time reviews of clinical study documentation from initiation through completion and escalate non-compliance events.
• Perform internal process audits according to ISO 19011 and participate in sponsor, accreditation-body, and regulatory audits.
• Monitor KPIs, study timelines, and deliverables while collaborating with operational leaders, cross-functional teams, and subject-matter experts.
• Create a cross-training course list to ensure qualified backup QA support across North America.

Requirements

• Bachelor’s degree in biology, microbiology, chemistry, biochemistry, business administration, quality assurance, regulatory compliance, or a related field.
• At least 3 years of professional quality assurance experience and 2 years in a QA or operational leadership role.
• Experience working in a GCP environment is required.
• At least 1 year of Lead Auditor experience or 3 years supporting an auditing team.
• At least 2 years of clinical monitoring experience.
• Strong knowledge of GCP and regulatory systems, including ISO, FDA, ICH, and compliance and auditing techniques.

Nice to have

• Experience with GDP, GLP, and ICH E6 standards.

Culture & Benefits

• Medical, dental, and vision insurance.
• Life insurance and employee assistance programs.
• 401(k) plan with company match and immediate vesting upon enrollment.
• Online and classroom training, development experiences, and tuition reimbursement.
• Paid time off and family leave.