Senior Quality Control Specialist – Method Validation & Technical Support

Role Overview

As a Senior Quality Control (QC) Specialist focusing on method validation and technical support, you will provide crucial scientific and technical guidance across QC operations. Your responsibilities will span the full spectrum of analytical method lifecycle activities, managing equipment qualification, spearheading investigations, fostering compliance, and leading ongoing improvement projects. Acting as a subject matter expert, you will partner with testing laboratories to ensure that analytical methods, laboratory equipment, and processes consistently meet evolving regulatory standards and industry benchmarks.

Key Responsibilities

• Direct all phases of analytical method management, including qualification, validation, verification, transfer, and ongoing oversight for both chemical and biological assays.
• Coordinate the complete lifecycle qualification of laboratory equipment, analytical instruments, and vital reagents in alignment with compliance expectations.
• Oversee the integration of new analytical techniques, advanced technologies, materials, and instrumentation within QC functions.
• Administer and evaluate stability programs, perform comprehensive data review, and identify key trends.
• Lead investigations into deviations, non-conforming outcomes, out-of-specification incidents, and unusual results; conduct detailed root cause analyses and facilitate the implementation of CAPA (Corrective and Preventive Actions).
• Stay up-to-date and execute necessary adjustments to ensure continuous compliance with changing GMP, FDA, USP, EP, ICH, and other global regulatory frameworks.
• Prepare, scrutinize, and officially endorse GMP records, including SOPs, validation protocols, reports, change requests, deviations, and CAPA records.
• Deliver expertise as a technical SME, cultivating knowledge within QC teams through guidance and targeted training initiatives.
• Participate in internal, external, and regulatory audits as a technical leader for your areas of specialization.
• Champion process enhancements to optimize analytical methods, laboratory procedures, compliance adherence, and operational efficiency.
• Collaborate closely with peers in QC, QA, manufacturing, validation, regulatory, and global technical teams to drive cross-departmental projects.

Candidate Profile

• Possess at least a Bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Have a minimum of five years’ experience in pharmaceutical or biopharmaceutical QC, analytical development, or technical support within a GMP-governed setting.
• Demonstrable practical experience in analytical method validation, qualification, transfer, instrument IQ/OQ/PQ, stability programs, and investigations of OOS/OOT, deviations, CAPA, or change controls.
• In-depth understanding of GMP principles, method lifecycle management, regulatory requirements (FDA, USP, EP, ICH, PIC/S), and data integrity standards.
• Prior involvement in regulatory audits or acting as a SME highly regarded.
• Familiarity or experience with advanced modalities such as biologics, vaccines, cell & gene therapies, as well as digital laboratory systems like LIMS or CDS, is an advantage.
• Exemplary skills in analysis, problem-solving, technical writing, and cross-functional stakeholder management; must be capable of working both independently and collaboratively.

Benefits at Amaris Consulting

• Join an international organization comprising over 110 nationalities, fostering a richly diverse and collaborative environment.
• Benefit from a culture that values internal growth, with the majority of our leaders having progressed from entry-level roles.
• Access an extensive internal academy and more than 250 training modules to promote ongoing professional development.
• Take part in a dynamic office culture featuring regular team-building, afterwork events, and social engagement.
• Contribute to meaningful change through involvement in CSR initiatives, including the WeCare Together program.

Equal Opportunity Commitment

We uphold a policy of diversity and inclusion, welcoming applicants from all backgrounds regardless of gender, orientation, ethnicity, age, disability, or belief. We are committed to an environment where every team member can realize their fullest potential.

Recruitment Process Information

• Initial conversation via phone/video to discuss your profile and motivations.
• Multiple interviews with future team members and managers to assess skills and fit.
• Possible technical/case assessment relevant to the role.
• The process may vary depending on role specifics and seniority requirements; feedback and transparent communication are prioritized throughout.

About Amaris Consulting

Amaris Consulting is a global, independent consulting firm supporting organizations with their technology and business transformation needs. With projects spanning more than 60 countries, and expertise concentrated in digital, telecommunications, life sciences, and engineering business lines, we empower our 7,600 staff to deliver innovative solutions to over 1,000 client organizations worldwide.