Careers in Conventional and Complex Injectables

Job Description:

About ForDoz Pharma

ForDoz Pharma Corp. is a specialty pharmaceutical company focused on the development, manufacturing, and commercialization of complex injectable products. We are committed to delivering high-quality medicines while maintaining the highest standards of quality, compliance, and operational excellence.

We are seeking an experienced QA Compliance Specialist to support quality and regulatory compliance in a GMP pharmaceutical manufacturing environment, with a primary focus on data integrity, audit trail reviews, and CAPA remediation to support ongoing FDA commitments.

Location: East Windsor, New Jersey

Job Type: Full-Time, Onsite, Temporary (3–6 Months)

Key Responsibilities

• Review audit trails for laboratory and manufacturing instruments and computerized systems to identify data integrity issues and compliance gaps.
• Review GMP documentation, electronic records, batch records, protocols, and reports for accuracy, completeness, and compliance.
• Conduct initial investigations for NOEs, deviations, OOS results, and data integrity issues.
• Review investigation reports to ensure appropriate root cause identification and effective CAPA implementation.
• Track investigations and CAPAs, monitor progress, and escalate overdue or critical issues to QA management.
• Support internal audits, regulatory inspections, aseptic process simulations, and manufacturing activities as required.
• Provide guidance to cross-functional teams on cGMP, GDP, data integrity requirements, and company SOPs.
• Other duties as assigned

Qualifications

• Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific field, or 10+ years of relevant pharmaceutical industry experience.
• Minimum 5+ years of pharmaceutical Quality Assurance experience.
• Significant hands-on experience in data integrity, audit trail reviews, and GMP documentation.
• Strong knowledge of FDA data integrity expectations, ALCOA+ principles, cGMP, and GDP.
• Experience with CAPA remediation, investigations, and internal audits.
• Experience in aseptic processing and regulatory inspections preferred.
• Strong analytical, organizational, and communication skills, with the ability to manage multiple priorities.

Pay: $35 – $45 per hour

Assignment Duration: Anticipated 3–6 months, subject to business needs.

** Visa Sponsorship: This position is not eligible for employment visa sponsorship now or in the future

Equal Opportunity Employer ForDoz Pharma Corp. is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.