Senior QC Associate - New Product Introduction

Ascend Project Management; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Ascend Project Management seeks a Senior Associate Quality Control to support NPI activities in a biopharma manufacturing setting. You will coordinate analytical testing, method validation and data management while maintaining strict cGMP compliance.

The role requires a scientific degree and 2–3 years’ QC or GMP lab experience, with strong analytical and documentation skills. On-site, full-time, with regular training and audits support.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 2–3 years of biopharmaceutical QC, GMP lab, pharma or medical-device industry experience.
• Strong background in chemistry and analytical testing.
• Experience in a cGMP-regulated manufacturing or testing environment.
• Knowledge of GMP laboratory principles, standards and regulatory requirements.
• Experience with analytical method validation, method transfer or equipment qualification is desirable.
• Experience preparing, reviewing and approving GMP documentation (procedures, protocols, investigations, change controls).
• Strong analytical and problem-solving skills with data interpretation.
• Ability to anticipate problems and implement preventative actions.
• Excellent technical writing, presentation and communication skills.
• Independent work with minimal supervision and right-first-time results.
• Strong organizational skills for multiple complex tasks.
• Ability to drive continuous improvements.
• Experience auditing documentation and processes.
• Aseptic compliance understanding in manufacturing.
• Regulatory agency interactions are desirable.

Responsibilities

• Act as Quality Control representative for NPI activities and routine product meetings.
• Support QC projects and QC activities within wider site projects.
• Plan and perform non-core testing for NPI activities.
• Manage sample-related activities for NPI projects across the site.
• Create, own, review and approve protocols, sample plans, SOPs and other docs.
• Coordinate analytical method validations and method transfers.
• Manage sample shipments and temperature-monitoring activities.
• Coordinate LIMS data for NPI and related testing.
• Plan and perform complex routine and non-routine analytical methods and assays.
• Review and approve laboratory results and supporting documentation.
• Troubleshoot issues and communicate solutions to stakeholders.
• Initiate and implement changes to controlled documents.
• Write protocols and support assay validation and equipment qualification.
• Introduce new lab techniques and method transfers.
• Conduct laboratory investigations when required.
• Ensure regulatory compliance in lab practices.
• Participate in audits and continuous-improvement initiatives.
• Maintain training and health & safety compliance.

Skills

Analytical testing

Chemistry background

GMP knowledge

Method validation

Method transfer

Equipment qualification

Technical writing

Communication

Problem solving

Independent work

Organizational skills

Regulatory interactions

Auditing documentation

Aseptic manufacturing

Education

Bachelor’s degree in a scientific discipline

Job description

Ascend Project Management seeks a Senior Associate Quality Control to support NPI activities in a biopharma manufacturing setting. You will coordinate analytical testing, method validation and data management while maintaining strict cGMP compliance.

The role requires a scientific degree and 2–3 years’ QC or GMP lab experience, with strong analytical and documentation skills. On-site, full-time, with regular training and audits support.