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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) ...

Job Description

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

Skills:

  • 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.

Qualifications:

  • 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
  • Lab background

Organizational Relationship:

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