QC Document Specialist
This role will provide non-testing support for raw material testing for a new and existing product in a cGMP Quality Control Analytical (QCA) department. This support includes writing and revising technical documents (procedures, test methods, raw material specifications) for new and existing raw materials associated with cGMP testing, compendial updates, investigations, change controls, method verification/validation, LabWare Laboratory Information Management System (LIMS) support, visual management, and continuous improvement. The candidate will be responsible for documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs). Organize and prioritize workload with the manager to meet all timelines and deliverables in the support of the plan of record and to ensure compliance.
Revise and author GMP documents
Author GMP laboratory investigations
Author change control documents
Write protocols, investigations
Evaluate compendial changes and impact on GMP procedures and specifications
Evaluate the impact of changes on the laboratory information management system (LIMS)
Create change requests for LIMS
Support continuous improvement projects and actions
Manage projects and coordinate timelines with stakeholders
Use of electronic documentation systems.
Support raw material department
Proficiency with computer systems (Microsoft Office applications, etc.)
Experience with electronic document systems is highly preferred
Knowledge and understanding of cGMP and industry standards
Experience working in cGMP USP/EP/JP, regulatory environment strongly preferred
A detail-oriented approach to deliverables as the main job responsibility is the generation and revision of GMP documentation.
Strong oral and written communication skills
Ability to work in a matrix environment
Ability to adapt to change in priorities and timelines
Dedicated and team orientated who is highly motivated and takes initiative, seeks out assignments
Normal lifting, sitting, standing and walking requirements to facilitate work in an office environment.
A BS degree in science, engineering, computer science, or related technical discipline.
Minimum 3-5 years pharmaceutical/biopharmaceutical experience in a relevant GMP role such as QC or QA
Past experience working with QC documentation in the biopharmaceutical field is preferred
QC Analytical Management
Material’s Program Team (cross-functional)
QC Analytical Raw Materials laboratory analysts
QC Analytical Raw Materials validation scientists