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Quality Control Document Specialist
Ref No.: 18-25743
Location: Andover, Massachusetts
Job Description:
Job Title: QC Document Specialist
Location: One Burtt Road, Andover, MA 01810
Duration: 15 Months
 
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).
  • 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 Materials validation scientists
•             QA
Years of Experience 3-5 Minimum
  • Position Comments: 15 months assignment
  • 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
Additional 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 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.
What is the minimum education experience required?:
  • 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