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Quality Assurance - Clinical II
Ref No.: 18-14883
Location: Andover, Massachusetts
Job Description: QC Document Specialist

This role will provide non-testing support for raw material testing for 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 documentation support as an individual and through collaboration with laboratory subject matter experts (SMEs) at Pharmaceutical. Organize and prioritize workload with 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
• Evaluate compendial changes and impact on GMP procedures and specifications
• Evaluate impact of changes on laboratory information management system (LIMS)
• Create change requests for LIMS
• Support continuous improvement projects and actions
• Manage projects and coordinate timelines with stakeholders

Organizational Relationship:

• QC Analytical Management
• Material’s Program Team (cross-functional)
• QC Microbiology
• QC Analytical Raw Materials laboratory analysts
• QC Analytical Raw Matertials validation scientists
• QA

Years of Experience 3-5 Minimum
Position Comments visible to MSP and Supplier: 15 month assignment
Not more than $50/hr billed
Document Specialist with GMP Pharma experience
Write change controls, protocols, investigations
SOP and documentation experience
Support raw material department
QC lab knowledge, authorize doc, writing investigations, writing change controls. use of electronic documentation systems.
BA degree required in science related field
2-5 years of experience in Pharma/ Biopharma