Senior Quality Assurance Specialist (Pharmaceutical Manufacturing)

Location: Pennsville, New Jersey, United States

Salary: $82,000–$110,000 per year

Company

hirify.global is a global pharmaceutical CDMO that develops and manufactures active pharmaceutical ingredients and finished dosage forms across a network of international sites.

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 and support conditional and final material release.
• Ensure cGMP compliance for assigned manufacturing operations and complete assigned QMS activities.
• Prepare and review product, process, equipment, and computerized systems validation and qualification documentation.
• Host and conduct customer, internal, external, and GMP audits, and participate in regulatory inspections.
• Conduct environmental monitoring, review CMC sections of DMFs, and maintain QA databases.

Requirements

• Bachelor’s degree in microbiology, biology, chemistry, engineering, or an equivalent combination of education and experience.
• 3–5 years of quality assurance experience in a pharmaceutical manufacturing environment.
• Knowledge of cGMP requirements, including ICH Q7, FDA regulations, and 21 CFR Parts 210 and 211.
• Excellent communication, computer, organizational, and project management skills.
• Ability to work independently, manage priorities, meet deadlines, and collaborate effectively.

Nice to have

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

Culture & Benefits

• Opportunities for personal and professional growth in a collaborative environment.
• Work with a global pharmaceutical CDMO supporting the development and manufacture of medicines.
• Long-term opportunities to contribute to safety, quality, and sustainability.