Job Overview The QC Technical Transfer Specialist supports laboratory operations by conducting analytical testing, coordinating method transfer activities, reviewing quality data, and maintaining compliance documentation within a GMP-regulated pharmaceutical or biotechnology environment. This position plays a key role in ensuring testing accuracy, regulatory compliance, and continuous improvement of quality systems.
Key Responsibilities
Execute analytical testing of raw materials, in-process samples, finished products, and stability samples.
Assist with method transfers, qualification studies, and validation activities for laboratory processes and systems.
Review, verify, and document laboratory results in accordance with established quality standards.
Support investigations related to laboratory discrepancies, out-of-specification results, and process deviations.
Generate, review, and maintain quality records including deviations, CAPAs, change controls, and investigation reports.
Utilize laboratory software and quality systems such as Empower, SoftMax Pro, SoloVPE, LIMS, and Trackwise.
Participate in software qualification and validation efforts by executing test protocols and documenting outcomes.
Ensure adherence to GMP, GDP, Data Integrity, and internal compliance requirements.
Collaborate with Quality, Manufacturing, Validation, and Regulatory teams to support project objectives.
Contribute to continuous improvement initiatives and provide guidance on laboratory best practices.
Required Qualifications
Associate's degree in chemistry, Biochemistry, Microbiology, Biotechnology, Life Sciences, or a related scientific discipline.
3 5 years of experience in a Quality Control, Analytical Laboratory, or Quality Systems role within the pharmaceutical, biotechnology, or life sciences industry.
Experience working in a GMP-regulated environment.
Strong understanding of laboratory investigations, analytical testing, and quality documentation practices.
Familiarity with data review and compliance requirements related to regulated laboratories.
Effective written and verbal communication skills.
Ability to manage multiple priorities while maintaining attention to detail.
Preferred Qualifications
Experience supporting method transfers, assay qualifications, and validation activities.
Knowledge of quality systems including Deviations, CAPA, Change Control, and Risk Assessments.
Hands-on experience with laboratory applications such as Empower, LIMS, TrackWise, SoftMax Pro, or similar systems.
Understanding of Data Integrity principles and regulatory expectations.
Experience of participating in software validation or computerized system validation (CSV) activities.
Numbers & Facts
Location
Portsmouth, NH
Skills
Analysis Skillsunmatched
Assay Methodsunmatched
Best Practicesunmatched
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Chemistryunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Data Qualityunmatched
Detail Orientedunmatched
Documentationunmatched
GMP (Good Manufacturing Practices)unmatched
Investigative Reportsunmatched
Laboratoryunmatched
Laboratory Analysisunmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Managementunmatched
Laboratory Operationsunmatched
Laboratory Systemsunmatched
Laboratory Techniquesunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Materials Analysisunmatched
Materials Testingunmatched
Microbiologyunmatched
Multitaskingunmatched
Operational Auditunmatched
People Managementunmatched
Precision Testingunmatched
Presentation/Verbal Skillsunmatched
Quality Assurance Methodologyunmatched
Quality Controlunmatched
Quality Managementunmatched
Quality Metricsunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Risk Analysisunmatched
Risk Managementunmatched
Software Validationunmatched
System Validationunmatched
Technical Supportunmatched
Writing Skillsunmatched
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