QC Analyst 3

sgs-job-5926

Business Support
 New Hampshire
SoftMax Pro
Empower
SoloVPE
GMP
Method Validation
Software Validation
Data Integrity

Contract - 08 Months

Location : Portsmouth, NH 03801 The QC Analyst is responsible for supporting Quality Control activities and technical transfer within a regulated pharmaceutical environment. This role focuses on laboratory software, method and software validation, GMP documentation, data integrity, troubleshooting, and collaboration with cross-functional teams to ensure quality and timely completion of assigned activities.

Job Responsibilities:

  • Support Quality Control activities related to technical transfer and production operations
  • Apply company policies, procedures, and GMP requirements to complete assigned QC activities
  • Utilize laboratory software including SoftMax Pro, Empower, and SoloVPE
  • Support method and software validation activities, including writing GMP procedures and validation documents
  • Execute validation test scripts and maintain appropriate validation documentation
  • Act as a Subject Matter Expert (SME) for at least one laboratory software system
  • Collaborate with cross-functional teams to understand and prioritize technical requirements
  • Perform technical and root-cause analysis for software errors and laboratory system issues
  • Apply Data Integrity principles in accordance with applicable policies, guidelines, and procedures
  • Maintain assigned training requirements and complete training activities on time
  • Support laboratory computer systems and GMP Quality Systems such as TrackWise and LIMS
  • Interpret laboratory and quality data independently and with appropriate guidance
  • Perform complex and varied assignments accurately and within established timelines
  • Direct, control, and plan assigned tasks and projects
  • Prepare and maintain technical and GMP documentation
  • Communicate effectively with cross-functional teams through written and verbal communication
  • Complete assignments accurately and on time while maintaining a strong commitment to quality
  • Work effectively as a self-motivated team member in a collaborative environment
  • Maintain reliable attendance and work the entire assigned shift
  • Perform other duties as assigned

Skills:

  • SoftMax Pro
  • Empower
  • SoloVPE
  • GMP / cGMP
  • Pharmaceutical Industry
  • Method Validation
  • Software Validation
  • Validation Documentation
  • Validation Test Scripts
  • GMP Procedure Writing
  • Data Integrity
  • Laboratory Computer Systems
  • LIMS
  • TrackWise
  • Microsoft Word
  • Microsoft Excel
  • Microsoft PowerPoint
  • Quality Control Systems
  • Technical Transfer
  • Root Cause Analysis
  • Software Troubleshooting
  • Data Interpretation
  • Quality Systems
  • Technical Documentation
  • Cross-Functional Collaboration
  • Problem Solving
  • Written and Verbal Communication
  • Teamwork
  • Time Management
  • Attention to Detail

Education/Experience:

  • Bachelor's degree in a relevant scientific, technical, or life sciences discipline.

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