MSAT Documentation & Compliance Specialist

Actalent; New Jersey; On-site; USD 39,000 - 55,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan – Pre-tax and Roth

Life Insurance

Disability insurance

HSA

Transit benefits

Employee Assistance Program

PTO/Time Off

Job summary

Actalent is seeking a MSAT Support contractor to join our manufacturing sciences team in Allendale, NJ. The role focuses on creating and maintaining Master Batch Records (MBRs) and electronic batch records (eBRs) in alignment with GMP standards and process requirements.

You will translate paper MBRs into compliant electronic formats, support documentation for PQ activities, and drive change controls and CAPAs while collaborating across Manufacturing, Quality, and Supply Chain to meet timelines.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical field.
• Minimum of 2 years combined industry/academic experience in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for manufacture of cell therapy products.
• Demonstrated excellence in technical writing in the preparation of protocols and reports, presentations and/or other communications.

Responsibilities

• Produce high level of technical documents, such as Master Batch Records (MBRs), protocols, reports, SOPs, and work instructions.
• Develop, revise, and maintain MBRs/eBRs in compliance with GMP and regulatory requirements.
• Translate paper-based MBRs into compliant eBRs.
• Ensure alignment of MBRs/eBRs with process requirements, equipment capabilities, and quality standards.
• Create and revise APS documentation (Protocols, MBRs, eBRs, Risk Assessments, and Reports)
• Support configuration workflows, parameters, calculations, and logic within the eBR platform.
• Support PQ execution activities.
• Assist in authoring and executing PQ protocols/reports for eBR implementations.
• Troubleshoot routine eBR issues and elevate as needed.
• Own and drive change controls and CAPAs related to MBR, eBR and APS documentation.
• Collaborate cross functionally with Manufacturing, QA, QC, MST, SCM, and PM.
• Meet client-driven timelines and deliverables while managing multiple priorities.
• Participate in continuous improvement initiatives to optimize batch record accuracy, efficiency, and compliance.
• Perform impact assessments for changes to MBRs/eBRs and implement updates through change control processes.
• Execute assignments in alignment with pre-planned scope of work, timeline, and budget.
• Execute, manage and provide support for investigations, deviations, and CAPAs
• Own technology transfer activities such as creation of MBRs, eBRs, and protocol/report generation for APS.

Skills

Technical writing

Risk management

Document control

Cross-functional comms

Attention to detail

Problem solving

Education

Bachelor's degree in engineering/life sciences

2+ years GMP cell therapy experience

eBR platforms knowledge

Tools

Electronic Batch Records

Job description

Actalent is seeking a MSAT Support contractor to join our manufacturing sciences team in Allendale, NJ. The role focuses on creating and maintaining Master Batch Records (MBRs) and electronic batch records (eBRs) in alignment with GMP standards and process requirements.

You will translate paper MBRs into compliant electronic formats, support documentation for PQ activities, and drive change controls and CAPAs while collaborating across Manufacturing, Quality, and Supply Chain to meet timelines.