Onsite Pharma QA Lead: Compliance & Product Release

System One; East Windsor Township (NJ); On-site; USD 37,000 - 40,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Spending accounts

Life insurance

Voluntary plans

401(k) plan

Job summary

System One is seeking a Senior Quality Assurance Associate to join our onsite team in East Windsor, NJ. You will lead QA activities ensuring GDP, DSCSA, and regulatory compliance for incoming and released pharmaceutical products.

The role requires 2–3 years in QA within pharma, a B.S. degree, and strong data analysis, communication, and leadership abilities. Oracle experience and MS Office proficiency are plus points, with a focus on continuous improvement in quality operations.

Qualifications

• Minimum B.S. degree, preferably in a scientific field.
• 2–3 years of QA or pharma industry experience.
• Microsoft Office proficiency.
• GMP knowledge and regulatory understanding.
• Strong communication and teamwork skills.
• Organizational and leadership abilities.
• Ability to analyze data and identify improvements.

Responsibilities

• Lead receipt and inspection of pharmaceutical products for GDP, DSCSA, and regulatory compliance.
• Verify DSCSA serialization, lot traceability, and chain of custody documentation.
• Identify and manage suspect or illegitimate product reports.
• Monitor warehouse environmental conditions and storage compliance.
• Inspect returned goods for disposition and regulatory compliance.
• Write, revise, and approve QA documentation (SOPs, procedures, work instructions).
• Investigate deviations and nonconformances.
• Execute QA review and approval of product release documentation.
• Support continuous improvement in quality operations and regulatory compliance.

Skills

Attention to detail

Leadership

Data analysis

Communication skills

Education

B.S. degree in a scientific field

Tools

Oracle

Microsoft Office

Job description

System One is seeking a Senior Quality Assurance Associate to join our onsite team in East Windsor, NJ. You will lead QA activities ensuring GDP, DSCSA, and regulatory compliance for incoming and released pharmaceutical products.

The role requires 2–3 years in QA within pharma, a B.S. degree, and strong data analysis, communication, and leadership abilities. Oracle experience and MS Office proficiency are plus points, with a focus on continuous improvement in quality operations.