QC Specialist II

SGS_JOB_3671

Scientific
 New Hampshire
QC
Capa
investigation

Contract - 12 months

Location (mandatory): Portsmouth NH USA 03801 Small Description: The QC Specialist II will join the Quality Control department and assist with technical transfer activities, contributing to the testing and analysis of in-process samples, final product testing, and stability studies. This role requires familiarity with GMP (Good Manufacturing Practices) systems, quality records, and testing methodologies. The individual will work collaboratively to complete complex tasks while ensuring adherence to industry regulations, contributing to method transfers, instrument qualifications, and validation activities.

Job Responsibilities:

  •   echnical Transfer Support: Collaborate in the completion of technical transfer activities, ensuring a smooth transition of processes or methods between departments.
  •   Sample Testing: Run test samples for in-process, lot release, and stability studies. Conduct tests for investigations, method validations, and transfers.
  •   Data Analysis: Review assay results and interpret data. Identify deviations from accepted practices and apply corrective actions where necessary.
  •   Quality Records: Prepare and maintain quality records, including deviations, CAPAs, change controls, and test methods.
  •   Training: Train other team members and provide technical guidance on QC practices and software tools.
  •   Software Validation & Usage: Utilize laboratory computer systems (e.g., TrackWise, LIMS) and software such as SoftmaxPro, Empower, and SoloVPE. Write GMP procedures and validation documents, execute test scripts.
  •   Cross-Functional Collaboration: Communicate with cross-functional teams to understand and prioritize testing needs.
  •   Project Management: Lead projects related to method transfers, new instruments, and qualification processes.
  •   Problem Solving: Perform root-cause analysis on software errors and operational issues.
  •   Data Integrity & Compliance: Ensure compliance with Data Integrity policies and Lonza DI procedures in all activities.

Skills:

  •   Testing & Analysis: Experience in running in-process, lot release, and stability test samples, including technical aspects of method validation and investigation.
  •   GMP Systems: Familiarity with GMP quality systems such as TrackWise, LIMS, and validation protocols.
  •   Software Skills: Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint), and laboratory software like SoftmaxPro, Empower, and SoloVPE.
  •   Root Cause Analysis: Strong skills in identifying, analyzing, and resolving issues related to testing processes, data, and software systems.
  •   Documentation: Ability to write and manage quality records, including deviations, CAPAs, change controls, and test methods.
  •   Data Integrity: Knowledge and application of Data Integrity principles in all aspects of QC work.
  •   Regulatory Knowledge: Familiarity with pharmaceutical GMP regulations and industry standards.
  •   Communication: Strong verbal and written communication skills, including the ability to explain complex data and technical concepts to both technical and non-technical audiences.
  •   Technical Transfer & Validation: Experience or understanding of method transfer projects, software validation, and instrument qualifications.

Education/Experience:

  •   Education: Associate’s Degree in Microbiology, Biochemistry, or a related science field.
  •   Experience: Prior experience in a GMP-compliant environment within the pharmaceutical industry, with a focus on quality control testing, method validation, and cross-functional collaboration.

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