Senior Quality Assurance Associate

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

Job Title: Senior Quality Assurance Associate
Location: East Windsor, NJ
Type: Direct Hire
Compensation: $27 - $29
Work Model: Onsite - onsite
Hours: Monday through Friday, 10:30am to 7:30pm

Responsibilities

• Lead receipt and inspection of pharmaceutical products for compliance with GDP, DSCSA, and regulatory requirements.
• 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 and resolve deviations and nonconformances.
• Execute QA review and approval of product release documentation.
• Support continuous improvement activities to enhance Quality operations and regulatory compliance.

Requirements

• Minimum B.S. degree, preferably in a scientific field.
• 2-3 years of experience in Quality Assurance or a similar field within the pharmaceutical industry.
• Oracle experience (preferred).
• Good knowledge of Microsoft Office applications.
• Organizational and leadership skills.
• Excellent data collection and analysis skills.
• Keen attention to detail, and critical/logical thinking.
• Strong knowledge of GMP regulations and their application.
• Demonstrated ability to communicate technical information or complex situations clearly.
• Excellent verbal, written, and teamwork communication skills.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

• medical
• dental
• vision
• spending accounts
• life insurance
• voluntary plans
• participation in a 401(k) plan

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.