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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