QC Senior Analyst

Job DescriptionQC Senior Analyst MSD Dundalk Position Overview The QC Senior Analyst works as directed by the QC Manager/QC Associate Director according to company safety policies, cGMP and cGLP. Ensure that QC team objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. Essential Functions and Responsibilities (Includes, but are not limited to) The QC Senior Analyst, is responsible for: Operating as part of the QC team performing the allocated testing and laboratory-based duties.

Act as testing SME with QC department, participate in OOS investigations and supporting troubleshooting activities. Participate in QC Tier daily meetings and ensure effective communication of testing progress, deviations, escalation of potential cGMP or compliance issues etc. Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems.

Peer review of testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved. Support activities including general lab readiness, audit readiness and audit participation, laboratory equipment qualification and analytical method technical transfer, verification and validation. The QC Analyst is also responsible for: Contributing to a continuous improvement environment and bringing problem solving and troubleshooting capabilities.

Demonstrating a commitment to learning and personal development. Qualification and Skills Requirements (Includes but are not limited to) Minimum Education/Experience: Degree qualification (Science/Quality/Technical or related) 4 years of laboratory experience, including sampling, testing, reporting in the biotechnology and/or pharmaceutical industry. General competencies: Motivation to be an inspiring member of a high performing team and passion to build the future of MSD Dundalk.

Desire to continuously learn, improve and develop. Flexible and self-motivated. Required to work on their own initiative in addition to working as part of a team.

Ability to manage multiple priorities and know when to escalate issues for resolution. Excellent time management and organizational skills. Technical: Possess effective communication and presentation skills.

Proficient with IT e.g. Microsoft office. Good critical thinking and problem solving skills.

Good knowledge of cGMP, GLP, Quality Management Systems. Skills: GMP GLP Quality Management Systems TPBN1_IJ