The Fountain Group
Documentation Specialist | Ridgefield, NJ
Pay: $25-30/hr.
Shift: 2nd shift | Sun-Sat
12-month assignment with possibility for extension or conversion based on performance and budget.
Responsibilities
Review and verify Batch Production Records (BPRs) to ensure accuracy and compliance with internal specifications, cGMP regulations, and ISO 13485 standards.
Manage the full lifecycle of production documents, including creation, revision, approval, issuance, distribution, and archival.
Oversee printing, tracking, and control of production documentation such as BPRs, Bills of Materials (BOMs), Protocols, and Labels to maintain traceability and regulatory compliance.
Review daily and weekly production schedules and collaborate with cross-functional teams to ensure alignment, efficiency, and timely execution.
Maintain organized and compliant documentation systems using tools such as SAP and other relevant data management software.
Partner with departments including Quality, Regulatory Affairs, Supply Chain, and Production to support documentation improvements and ensure seamless communication.
Support ongoing compliance initiatives by identifying documentation gaps, implementing updates, and assisting with process optimization projects.
Uphold strict adherence to cGMP and ISO 13485 standards while contributing to inspection readiness and continuous improvement efforts.
Qualifications
High School Diploma required at a minimum
3+ years of experience within a cGMP regulated environment
required
Experience within pharma/medical device industry is
preferred
Experience reviewing and verifying BPRs (batch production records) and/or BOMs (bills of materials)
required
Experience with management of the lifecycle of production documents
highly preferred
Experience with ISO 13485 regulations
preferred
Experience with SAP
preferred
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Pay: $25-30/hr.
Shift: 2nd shift | Sun-Sat
12-month assignment with possibility for extension or conversion based on performance and budget.
Responsibilities
Review and verify Batch Production Records (BPRs) to ensure accuracy and compliance with internal specifications, cGMP regulations, and ISO 13485 standards.
Manage the full lifecycle of production documents, including creation, revision, approval, issuance, distribution, and archival.
Oversee printing, tracking, and control of production documentation such as BPRs, Bills of Materials (BOMs), Protocols, and Labels to maintain traceability and regulatory compliance.
Review daily and weekly production schedules and collaborate with cross-functional teams to ensure alignment, efficiency, and timely execution.
Maintain organized and compliant documentation systems using tools such as SAP and other relevant data management software.
Partner with departments including Quality, Regulatory Affairs, Supply Chain, and Production to support documentation improvements and ensure seamless communication.
Support ongoing compliance initiatives by identifying documentation gaps, implementing updates, and assisting with process optimization projects.
Uphold strict adherence to cGMP and ISO 13485 standards while contributing to inspection readiness and continuous improvement efforts.
Qualifications
High School Diploma required at a minimum
3+ years of experience within a cGMP regulated environment
required
Experience within pharma/medical device industry is
preferred
Experience reviewing and verifying BPRs (batch production records) and/or BOMs (bills of materials)
required
Experience with management of the lifecycle of production documents
highly preferred
Experience with ISO 13485 regulations
preferred
Experience with SAP
preferred
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