MBR Business Support Specialist - ONSITE - Sierra Solutions Group
Raritan, NJ 08869
About the Job
Job Summary
We are looking for an MBR Business Support Specialist for our Pharmaceutical client. As an MBR Business Support Specialist, you will play a critical role in ensuring the smooth functioning of pharmaceutical manufacturing operations. Your responsibilities will encompass administrative and operational tasks related to Master Batch Records (MBRs) throughout the product lifecycle. MBRs are essential documents that guide the production of pharmaceutical products, from raw material procurement to final packaging.
Primary Responsibilities
Education and Experience
We are looking for an MBR Business Support Specialist for our Pharmaceutical client. As an MBR Business Support Specialist, you will play a critical role in ensuring the smooth functioning of pharmaceutical manufacturing operations. Your responsibilities will encompass administrative and operational tasks related to Master Batch Records (MBRs) throughout the product lifecycle. MBRs are essential documents that guide the production of pharmaceutical products, from raw material procurement to final packaging.
Primary Responsibilities
- MBR Preparation and Review:
- Collaborate with cross-functional teams to prepare, review, and approve controlled MBRs.
- Utilize a risk-based systems approach to ensure compliance with current Good Manufacturing Practices (cGMPs).
- Work with both paper-based (pMBR) and electronic (eMBR) formats.
- Extend support to paper-based Batch Production Records (pBPRs), electronic Batch Production Records (eBPRs), or hybrid Batch Production Records (hBPRs).
- Document Control and Archiving:
- Assign unique identification numbers to each MBR and sequentially ordered numbers to each BPR.
- Maintain a GMP-compliant document control system for pMBRs, eMBRs, pBPRs, eBPRs, and hBPRs.
- Ensure proper origination, distribution, maintenance, and archiving of all GMP documentation within the department.
- Cross-Functional Collaboration:
- Support a Cross-Functional Team (CFT) approach by coordinating with qualified personnel from various functions and departments.
- Delegate authority while maintaining overall responsibility for MBR processes.
- Quality Assurance (QA) Oversight:
- Authorize and oversee the creation of MBR procedures.
- Define numbering and formatting conventions for MBRs.
- Record unique MBR and BPR identifying numbers in controlled logbooks or electronic tracking systems.
- Ensure compliance with quality risk assessment and good documentation practices.
Education and Experience
- Bachelor’s degree in a relevant field (e.g., life sciences, pharmaceuticals, business administration).
- Experience in pharmaceutical manufacturing, document control, or quality assurance.
- Familiarity with cGMPs and regulatory guidelines.
- Strong attention to detail and organizational skills.
- Excellent communication and teamwork abilities.
- The following skills are required: IQ, OQ, PQ, CSV, MBR Modeler, Werum PasX
Source : Sierra Solutions Group