Quality Engineer - GMP Documentation

Quality Engineer - GMP Documentation at Comrise Quality Engineer - GMP Documentation at Comrise in Pleasantville, New York Posted in 1 day ago.

Type:

full-time

Job Description:

Position Summary The Quality Engineer supports the Tarrytown Scale Up Facility (SUF) with a primary focus on batch record review, management, and documentation stewardship. The role partners with SUF operations, Tech Transfer, and Documentation teams at the Walpole manufacturing site, as well as R D teams in Tarrytown and Glasgow to ensure accurate, complete, and compliant manufacturing documentation. Secondary responsibilities include authoring and revising technical documents such as work instruction and procedures to support formulation scale-up, process readiness, and technology transfer activities. The ideal candidate is a detail oriented and a highly organized communicator who can work with subject matter experts to ensure documentation quality, consistency, and timely approval. Key Responsibilities Batch Record Review and Stewardship o Perform detailed batch record review to ensure accuracy, completeness, and compliance with established procedures and regulatory expectations. o Act as a documentation steward, ensuring alignment between batch records, work instructions, and supporting technical documents o Identify documentation gaps, inconsistencies, or risks and proactively communicate issues to subject matter experts and SUF leadership. Document Authoring and Revision o Author, revise, and update manufacturing documentation, including work instructions, procedures, technical reports, verification reports, and supporting studies. o Support updates to existing SUF work instructions to reflect process changes, scale-up activities, and tech transfer requirements. o Collaborate cross-functionally with R D, Manufacturing, Tech Transfer, and Documentation teams across multiple sites. o Participate in project- and department-level meetings to ensure timely and successful completion of documentation deliverables o Provide documentation support for pre-manufacturing product development activities as needed Required Knowledge, Skills, and Experience o 5 - 8 year of demonstrated experience in technical writing or batch record review within a scientific, engineering, or manufacturing environment o Strong understanding of documentation practices in regulated environments (GMP) o Strong ability to clearly communicate technical information to diverse audiences o Excellent interpersonal, collaboration, and customer-service skills o Proven ability to review detailed technical documentation with a high level of accuracy and attention to detail and quality o Strong organizational skills and ability to manage multiple documentation deliverables simultaneously Technical Skills High proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Visio Preferred Attributes o Experience supporting manufacturing, scale-up, or technology transfer activities. o Self-motivated and proactive communicator comfortable working with cross-functional teams o Strong organizational skills and documentation discipline o Comfortable working across sites and functions in a regulated environment