Manufacturing Engineering Documentation Specialist

About the Role

A&Z Pharmaceutical, Inc. is seeking a dynamic and detail-oriented Documentation Specialist in the pharmaceutical industry. This role involves creating, editing, and maintaining high-quality documentation, including Standard Operating Procedures (SOPs), regulatory submissions, batch records, and technical reports. The Documentation Specialist bridges the gap between complex scientific data and regulatory requirements, ensuring compliance with cGMP (current Good Manufacturing Practices) and FDA guidelines.

Key Responsibilities

• Standard Operating Procedure (SOP) Writing:
• Draft, edit, and maintain SOPs, validation protocols, and master batch records.
• Ensure all documents adhere to FDA and other regulatory standards, contributing to submissions and audits.
• Regularly review and update SOPs in line with technological or process changes.
• Execution of Equipment Qualification (IOPQ):
• Assist in the execution of IOPQ protocols for equipment and processes.
• Collaborate with senior team members to ensure protocols are followed accurately and completely.
• Document results and any deviations, reporting to the Technical Operations Manager.
• Support equipment qualification, calibration, and verification activities and ensure documentation is complete and accurate.
• Review and maintain calibration records and equipment documentation in accordance with established procedures.
• Technical Document Management:
• Organize, store, and manage technical documents in a systematic manner.
• Ensure easy access to documents for all relevant departments while maintaining security and confidentiality.
• Regularly review and update documents to ensure they are current and compliant.
• Identify gaps in current processes and update documentation to reflect improvements or correct deviations.
• Equipment Recordkeeping and Maintenance Scheduling:
• Maintain an up-to-date list of all equipment, including specifications, locations, calibration status, and maintenance status.
• Collaborate with the QA team to schedule and track regular equipment calibration and maintenance.
• Ensure calibration and maintenance activities are properly documented and completed within established timelines.
• Collaborate with the maintenance team to identify and address potential equipment issues.
• Change Control Management:
• Collaborate with the QA team to understand the implications and requirements of potential changes.
• Track and monitor the status of change controls, ensuring relevant stakeholders are kept informed.
• Assist in drafting initial change control requests, ensuring all relevant details are accurately captured.

Requirements & Tech Stack

• cGMP (current Good Manufacturing Practices)
• FDA guidelines
• MS Office Suite (Word, Excel)
• Document management systems

Qualifications

• Bachelor’s degree in Engineering (Required).
• Hands-on experience with equipment calibration and calibration documentation is required.
• 1–3 years of technical writing experience, ideally in pharmaceutical, nutraceutical, biotechnology, or medical device environments.
• Experience with equipment qualification, validation, calibration, or maintenance documentation preferred.
• Meticulous approach to reviewing and editing to prevent errors in manufacturing or reporting.
• Training will be provided to the right candidate.
• Recent engineering graduates are encouraged to apply.