Sr. Quality Assurance Specialist

Location: Pennsville, New Jersey, United States

Salary: $82,000–$110,000 per year

Company

hirify.global is a global contract development and manufacturing organization serving the pharmaceutical industry, with capabilities spanning API and finished dosage form development and manufacturing.

What you will do

• Review, approve, and track executed production records, Master Production Records, QC investigations, and laboratory results.
• Conduct, write, and review quality-related investigations, GMP inspections, and environmental monitoring activities.
• Prepare and review product, equipment, and computerized systems validation and qualification documentation.
• Support conditional and final material release, QMS activities, QA databases, and CMC sections of drug master files.
• Host and conduct customer, internal, and external audits and participate in regulatory authority inspections.
• Maintain cGMP compliance for assigned manufacturing operations and areas.

Requirements

• BA/BS degree in microbiology, biology, chemistry, or engineering, plus 3–5 years of QA experience in pharmaceutical manufacturing, or an equivalent combination of education and experience.
• Knowledge of cGMP requirements and pharmaceutical manufacturing regulations, including ICH Q7, FDA requirements, and 21 CFR 210/211.
• Excellent communication, computer, organization, and prioritization skills.
• Ability to manage projects, meet deadlines, work independently, and collaborate as part of a team.
• Conscientious and detail-oriented approach to quality work.

Nice to have

• Thorough knowledge of cGMP practices in active pharmaceutical ingredient manufacturing.

Culture & Benefits

• Opportunities for personal and professional growth within a rapidly expanding global organization.
• Collaborative environment bringing together diverse perspectives and experience.
• Work focused on safety, quality, sustainability, and pharmaceutical manufacturing impact.
• Long-term opportunities to contribute to pharmaceutical development and manufacturing.