Senior QC Specialist (Method Validation & Technical Support)

Job description

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.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!