Quality Assurance Associate Job at System One Holdings, LLC, Hightstown, NJ

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  • System One Holdings, LLC
  • Hightstown, NJ

Job Description

Job Title: Quality Assurance Associate
Location: East Windsor, NJ
Type: Contract To Hire
Compensation: Pay Rate - hourly: $30-$40/hr
Contractor Work Model: Onsite
Hours: 40.0

Responsibilities



  • Ensure cGMP compliance across all project and product-related activities
  • Support and maintain the Quality Management System (QMS)
  • Manage quality activities for assigned projects/products, ensuring audit readiness at all times
  • Participate in new product introduction and ongoing product lifecycle support
  • Collaborate with suppliers and Procurement on supplier qualification and quality oversight
  • Review and approve documentation (SOPs, protocols, reports, batch records, specifications)
  • Support deviations, change controls, CAPAs, and ensure timely closure
  • Assist with internal and external audits, ensuring inspection readiness
  • Monitor and support quality metrics (KPIs) and continuous improvement initiatives
  • Provide QA support across areas such as: Raw materials & suppliers, Production processes, Validation & qualification, Stability programs, Batch release & cleaning, Customer complaints & audits
  • Maintain regular presence on the manufacturing floor to support operations
  • Ensure compliance with HSE (Health, Safety & Environment) standards
  • Support investigation of customer complaints and quality issues
  • Promote a quality-first, continuous improvement culture
Requirements
  • Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, (required)
  • Exposure to QA in a GMP environment within pharma (preferred)
  • Experience working in a GMP-regulated operational environment (preferred)
  • Working knowledge of GMP standards and practices
  • Basic understanding of Regulatory Affairs (preferred)
  • Strong documentation skills and attention to detail
  • Proficient in MS Office (Word, Excel, etc.)
  • Ability to follow procedures and operate within strict compliance frameworks
  • Industry Experience: Pharmaceutical (preferred)



System One, and its subsidiaries including Joulé and 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.

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Ref: #558-Scientific

Job Tags

Hourly pay, Contract work, For contractors, Local area

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