What are the responsibilities and job description for the Senior Quality Assurance Associate position at System One?
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.
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.
#LI-
Ref: #558-Scientific
Salary : $27 - $29