The document specialist 1 is an associate with a minimal level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a good understanding of current GMP and safety standards. The DS1 collaborates with subject matter experts and technical specialists to plan, develop, author, edit, format, illustrate, update, and create new standard operating procedures and other related documentation such as PBRs, logbooks, job aids and technical reports in support of the cGMP compliant Manufacturing facility. Responsibilities include maintaining established documentation design and quality standards, using performance tools (Human Performance) and managing documentation workflows to meet departmental needs. Additional responsibilities may include administrative duties to manage and process controlled documents for the manufacturing facility.
ESSENTIAL JOB FUNCTIONS:
- Collaborates with area SMEs or technical specialist to create or revise existing procedures or documents for use in the manufacturing facility.
- Obtains and verifies accuracy of technical details, manages documentation workflows and schedules and proofreads drafts for adherence to established document design and quality standards.
- Performs administrative duties related to managing controlled document life cycles from issuance to Manufacturing through archival with Quality Assurance.
- Responsibilities may include maintaining the GMP manual of Standard Operating Procedures and management of logbooks for the manufacturing operations.
- Provides training to junior associates on established writing standards for documentation design and quality.
- Training provided may also include company policies, programs and procedures commensurate with their experience as a qualified trainer.
- Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.