Quality Engineer

Quality Engineer at GForce Life Sciences Quality Engineer at GForce Life Sciences in Briarcliff Manor, New York Posted in 41 minutes ago.

Type:

full-time

Job Description:

Quality Engineer 12-month Contract On-site in Tarrytown, NY Overview The Quality Engineer supports a scale-up manufacturing facility with a primary focus on batch record review, management, and documentation stewardship. This role partners with Operations, Tech Transfer, Documentation, Manufacturing, and R D teams across multiple sites to ensure accurate, complete, and compliant manufacturing documentation. Secondary responsibilities include authoring and revising technical documents such as work instructions and procedures to support formulation scale-up, process readiness, and technology transfer activities. The ideal candidate is detail-oriented and a highly organized communicator who can work with subject matter experts to ensure documentation quality, consistency, and timely approval. Requirements Batch Record Review and Stewardship Perform detailed batch record review to ensure accuracy, completeness, and compliance with established procedures and regulatory expectations. Act as a documentation steward, ensuring alignment between batch records, work instructions, and supporting technical documents. Identify documentation gaps, inconsistencies, or risks and proactively communicate issues to subject matter experts and leadership. Document Authoring and Revision Author, revise, and update manufacturing documentation, including work instructions, procedures, technical reports, verification reports, and supporting studies. Support updates to existing work instructions to reflect process changes, scale-up activities, and tech transfer requirements. Collaborate cross-functionally with R D, Manufacturing, Tech Transfer, and Documentation teams across multiple sites. Participate in project- and department-level meetings to ensure timely and successful completion of documentation deliverables. Provide documentation support for pre-manufacturing product development activities as needed. Qualifications Required Knowledge, Skills, and Experience 5-8 years of demonstrated experience in technical writing or batch record review within a scientific, engineering, or manufacturing environment. Strong understanding of documentation practices in regulated environments (GMP). Strong ability to clearly communicate technical information to diverse audiences. Excellent interpersonal, collaboration, and customer-service skills. Proven ability to review detailed technical documentation with a high level of accuracy and attention to detail and quality. 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 Experience supporting manufacturing, scale-up, or technology transfer activities. Self-motivated and proactive communicator comfortable working with cross-functional teams. Strong organizational skills and documentation discipline. Comfortable working across sites and functions in a regulated environment