Senior QC Specialist (Method Validation & Technical Support) - #1162909

The Senior QC Specialist (Method Validation & Technical Support) is responsible for providing technical and scientific leadership to Quality Control (QC) operations through the management of analytical method lifecycle activities, equipment qualification, investigations, compliance initiatives, and continuous improvement programs.

This role serves as a key technical Subject Matter Expert (SME) supporting method development, qualification, validation, verification, equipment qualification, compendial compliance, and regulatory readiness activities. The incumbent will work closely with routine testing laboratories to ensure analytical methods, equipment, and laboratory processes remain compliant with applicable regulatory requirements and industry best practices.

ABOUT THE JOB

• Lead analytical method qualification, validation, verification, transfer, and lifecycle management for chemical and biological testing.

• Manage qualification of laboratory equipment, analytical instruments, and critical reagents, ensuring compliance throughout their lifecycle.

• Support introduction of new methods, technologies, materials, and equipment into QC operations.

• Coordinate and maintain QC stability programs, including data review and trend analysis.

• Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events; perform root cause analysis and drive CAPA implementation.

• Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements.

• Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs.

• Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams.

• Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas.

• Drive continuous improvement initiatives to enhance analytical methods, laboratory processes, compliance, and operational efficiency.

• Collaborate with cross-functional teams including QC, QA, Manufacturing, Validation, Regulatory Affairs, and Global Technical functions.

ABOUT YOU

• Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.

• Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment.

• Hands-on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls).

• Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles.

• Experience supporting regulatory inspections, audits, and acting as a technical Subject Matter Expert (SME) is highly preferred.

• Exposure to biologics, vaccines, sterile manufacturing, cell & gene therapy, LIMS, CDS, electronic quality systems, or laboratory digitalization initiatives is an advantage.

• Strong analytical, problem-solving, technical writing, stakeholder management, and cross-functional collaboration skills, with the ability to work independently, drive continuous improvement initiatives, and provide effective training and knowledge transfer.

WHY AMARIS?

At Amaris Consulting, we believe in creating a thriving, positive workplace where every team member can grow, connect, and make a real impact. Here’s what you can expect when you join our dynamic community:

• Global Diversity: Be part of an international team of 110+ nationalities, celebrating diverse perspectives and collaboration.

• Trust and Growth: With 70% of our leaders starting at entry-level, we’re committed to nurturing talent and empowering you to reach new heights.

• Continuous Learning: Unlock your full potential with our internal Academy and over 250 training modules designed for your professional growth.

• Vibrant Culture: Enjoy a workplace where energy, fun, and camaraderie come together through regular afterworks, team-building events, and more.

• Meaningful Impact: Join us in making a difference through our CSR initiatives, including the WeCare Together program, and be part of something bigger.

Equal opportunity

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.