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Document Control Specialist, QA

System One
  • Pennington, NJ
  • $31 Per Hour
  • Instant Apply
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System One

Job Description

Job Title: Document Control Specialist, QA
Location: Pennington, NJ
Type: Contract to Hire
Pay Rate: $31.00 per hour
Hours: Monday-Friday 9am-5pm

Overview:
Under the oversight of the Quality Assurance Leadership, this position is responsible for providing quality and operational oversight of Document Control, Records Retention, and Archive Management activities. The role works closely with site and global teams to ensure compliant documentation practices, effective records management, archival governance, and sustained inspection readiness

Responsibilities:
  • Serve as Business Process Owner (BPO) and Subject Matter Expert (SME) for Document Control, Records Retention, and Archive Management processes.
  • Oversee document lifecycle management, records retention, archival activities, and related systems to ensure compliance with GMP, quality, and regulatory requirements.
  • Manage controlled document issuance and logbooks, records inventories, retention schedules, archival requests, record retrieval.
  • Monitor process performance, maintain inspection readiness, and support audits through documentation management and SME participation.
  • Collaborate with local and global cross-functional teams to ensure alignment with corporate standards and best practices.
  • Maintain oversight of documents, records, and archive workflows, including reporting, periodic reviews, and system administration activities.
  • Review of GMP records (such as production records, cleaning records, line clearance records, QC records etc.)
  • Review executed validation documents and protocols
  • Other duties as assigned


Requirements:
  • Bachelor's degree preferred in Life Science, Science, or a Regulatory-related field, and/or equivalent experience.
  • Minimum of 3-5 years within the GMP industry, including demonstrated experience providing quality oversight in a manufacturing and/or warehouse environment.
  • Demonstrated ability to lead, influence, and communicate across multisite, multi-cultural teams.
  • Capable of clearly explaining, coaching, and supporting cross functional teams through Document Management processes and best practices.
  • Able to articulate and defend Document Control principles, rationale, and compliance expectations during internal and external audits.
  • Strong understanding of GMP principles and expectations, with the ability to apply them effectively in daily operations.
  • Proficient in Quality Systems processes, including their purpose, interdependencies, and execution in a regulated environment.
  • Internal and external audit experience is preferred.
  • Master Control experience is strongly preferred.


Ref: 558-Scientific
#M-3
#LI-MM1


Ref: #558-Scientific


Numbers & Facts

LocationPennington, NJ
IndustryStaffing/Employment Agencies
Company Size2,500 to 4,999 employees
Websitehttps://systemone.com

About Company

Every day, System One focuses on services and solutions that require a high degree of specialization, in-demand technical skills, and large-scale operational expertise. We are essential partners to those on the front lines of our nation’s most critical infrastructure, technology, and life sciences initiatives. 

Founded more than 40 years ago as a staffing partner to the engineering industry, today System One is a diversified organization operating in over 50 locations and putting more than 9,000 people to work in the United States, Canada, and the United Kingdom.

Skills

  • Auditingunmatched
  • Best Practicesunmatched
  • Biologyunmatched
  • Business Processesunmatched
  • Coachingunmatched
  • Communication Skillsunmatched
  • Consultingunmatched
  • Cross-Functionalunmatched
  • Document Controlunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • External Auditunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Internal Auditunmatched
  • Inventory Reportsunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Multiculturalunmatched
  • Operationsunmatched
  • Performance Analysisunmatched
  • Quality Assuranceunmatched
  • Quality Controlunmatched
  • Records Managementunmatched
  • Regulationsunmatched
  • Regulatory Requirementsunmatched
  • Support Documentationunmatched
  • Systems Administration/Managementunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched
  • Warehousingunmatched

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