Job Opening for QC Specialist II

Title: QC Specialist II
Location: Portsmouth NH
Duration: 12 Months
100% On site

Position Overview
We are seeking a QC Specialist II to join the Quality Control team in Portsmouth, NH . This role supports production and laboratory operations through technical transfer activities, analytical testing, and quality system documentation within a GMP-regulated pharmaceutical environment .
The QC Specialist II will perform in-process, lot release, and stability testing , support method transfers and validations , and contribute to quality investigations and continuous improvement initiatives . The ideal candidate will have experience working with GMP quality systems, laboratory software, and analytical instrumentation while ensuring compliance with data integrity and regulatory requirements .

Key Responsibilities
Quality Control & Analytical Testing

• Perform analytical testing for in-process samples, lot release, and stability studies .
• Conduct testing to support investigations, method transfers, and validation activities .
• Review analytical assays and laboratory results to ensure accuracy and compliance.
• Support laboratory operations by troubleshooting testing issues and identifying deviations from standard procedures.

Technical Transfer & Laboratory Projects

• Support technical transfer activities within the Quality Control laboratory.
• Participate in method transfers, new instrument implementation, and method qualification projects .
• Assist with the validation and qualification of laboratory software and analytical systems .
• Serve as a Subject Matter Expert (SME) for at least one laboratory software system.

Quality Systems & Documentation

• Author and review GMP documentation , including:
  • Deviations
  • CAPA records
  • Change controls
  • Investigation reports
  • Test methods and procedures
• Participate in root cause investigations and support corrective and preventive actions.
• Ensure compliance with data integrity (DI) policies, procedures, and regulatory requirements .
• Maintain accurate laboratory records in accordance with GMP and regulatory guidelines .

Collaboration & Communication

• Communicate with cross-functional teams to support project priorities and technical needs.
• Provide training and guidance to other team members when needed.
• Interpret analytical data and present findings to internal stakeholders.
• Participate in team meetings and contribute to continuous improvement initiatives.

Required Qualifications

• Associate’s Degree in Microbiology, Biochemistry, or a related scientific field .
• Experience working in a GMP-regulated pharmaceutical or biotechnology environment .
• Experience with quality systems and documentation including deviations, CAPA, investigations, and change control.
• Strong understanding of data integrity principles and regulatory compliance.
• Ability to analyze data, troubleshoot issues, and support root-cause investigations.
• Strong written and verbal communication skills

Technical Skills
Experience with the following systems and software is preferred:

• SoftMax Pro
• Empower
• SoloVPE
• LIMS
• TrackWise
• Microsoft Office Suite (Word, Excel, PowerPoint)

Additional experience with software validation activities , including writing GMP procedures, validation documents, and executing test scripts , is highly desirable.
Core Competencies

• Strong analytical and problem-solving skills
• Ability to manage multiple priorities and projects
• Excellent communication and teamwork skills
• High attention to detail and commitment to quality and compliance
• Self-motivated with the ability to work independently and within a team environment

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