Analytical Quality Specialist

Katalyst CRO; Portsmouth (NH); On-site; USD 95,000 - 125,000; Full time

Job summary

Katalyst CRO is seeking a QC Technical Transfer Specialist to support laboratory operations, conduct analytical testing, and coordinate method transfer activities within a GMP-regulated environment.

You will review quality data, maintain compliance documentation, and collaborate with Quality, Manufacturing, Validation, and Regulatory teams to drive project objectives and continuous improvement of quality systems.

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.

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.

Skills

Analytical testing

GMP

Documentation

Data integrity

Cross-functional collaboration

Education

Associate's degree in chemistry

Tools

Empower

LIMS

TrackWise

SoftMax Pro

Job description

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.

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.
• 35 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.