Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

The Batch Record Reviewer - Documentation Specialist will provide direct support to the Production team for documentation and training activities. This role is essential in ensuring the accuracy and compliance of Batch Manufacturing Records (BMR) and other production documentation. The specialist will also support and deliver training for the production team on documentation completion .

Responsibilities

Supporting the review of batch manufacturing records, including trending of errors and feedback to production operators to ensure continuous improvement.Ensuring the timely closure of batch manufacturing steps in SAPProvide support on documentation required for productionDraft of the manufacturing documentation (Master Batch Record), in collaboration with the Technology Transfer and the Cleaning & Process Validation groupAuthoring and reviewing production documentation, such as Standard Operating Procedures (SOPs), Training Forms, Risk Assessments, and Audit Trail Reviews using the Electronic Documentation Management System.Coordinating investigations in error to generate preventative actionsOwn change control related to BMR and documentation.AttendTier 1 huddles to update teams on relevant Batch Record positionTrack Progress of Batch Record reviewUsing Practical Process Improvement to drive improvement initiative of our Batch Record and other documentations.

Minimum Requirements/Qualifications:

To thrive in this role, you should possess the following qualifications and experience:

Proven working knowledge of the principles and guidelines for Good Manufacturing Practice (GMP) related to production activities, documentation, and data integrity requirements.A minimum of 5 years’ experience in pharmaceutical manufacturing, with a preference for specific experience in sterile filtration products.Strong proficiency in Microsoft Office applications and a high level of general computer literacy.Demonstrated experience in effectively collaborating with collaborators, including colleagues, senior management, and customers.