QC NPI Senior Associate

Ascend Project Management, Inc.; Dublin; On-site; EUR 54,000 - 65,000; Full time

Job summary

Ascend Project Management, Inc. seeks a Quality Control NPI Senior Associate for a South Dublin site to support New Product Introduction activities.

The role requires independent work across QC, Process Development and Manufacturing Operations, handling analytical testing and data management. The successful candidate will act as QC representative for NPI meetings, coordinate sample management, create SOPs and controlled documents, and contribute to regulatory audits while ensuring cGMP

Qualifications

• Bachelor’s degree in Science or related field.
• 2–3 years’ biopharmaceutical QC, GMP lab experience.
• Experience in a cGMP-regulated analytical lab.
• Strong understanding of GMP, Data Integrity and regulatory expectations.
• Hands-on with analytical technologies (HPLC, rCE-SDS).
• Ability to plan and perform routine and non-routine testing.
• Strong writing skills for investigations, SOPs and change controls.
• Experience with data management and LIMS.

Responsibilities

• Act as QC representative for NPI activities and product meetings.
• Support QC projects and delivery of QC activities within site projects.
• Plan and perform non-core analytical testing for NPI.
• Coordinate sample management for NPI programmes.
• Create and maintain sample plans, SOPs and controlled documents.
• Coordinate LIMS data for non-core and NPI activities.
• Review and approve laboratory results and data.

Skills

HPLC

rCE-SDS

GMP knowledge

Data integrity

Analytical testing

Education

Bachelor’s degree in Science

Tools

LIMS

HPLC

rCE-SDS

Job description

Job Description: Quality Control NPI Senior Associate

Our client is a leading global biopharmaceutical organisation with a state-of-the-art manufacturing facility in South Dublin. The site specialises in the manufacture and supply of high-quality biologic medicines and operates within a highly regulated cGMP environment.

Our client is seeking Quality Control NPI Senior Associates to support New Product Introduction activities within its Quality Control function. The successful candidates will act as QC representatives for NPI activities and product-related meetings, supporting QC, Process Development and Manufacturing Operations. The role will involve analytical testing, sample and data management, documentation ownership and the coordination of laboratory activities required to support the successful introduction of new products.

This is a site-based position requiring strong technical flexibility, analytical capability and the ability to work independently across a range of QC activities.

Key Responsibilities

• Act as the Quality Control representative for New Product Introduction activities and routine product meetings.
• Support QC projects and the delivery of QC-related activities within wider site projects.
• Plan and perform non-core analytical testing associated with NPI activities.
• Coordinate sample management activities for NPI programmes across the site.
• Create and maintain sample plans, SOPs and other controlled documentation supporting NPI activities.
• Coordinate LIMS data associated with non-core and NPI activities.
• Plan and perform complex routine and non-routine analytical methods and assays efficiently and accurately.
• Review, evaluate, trend, approve, archive and maintain analytical data.
• Troubleshoot technical issues, investigate problems and communicate findings to relevant stakeholders.
• Initiate and implement changes to controlled documents.
• Conduct or support laboratory investigations as required.
• Continuously evaluate laboratory practices to ensure ongoing cGMP and regulatory compliance.
• Review and approve laboratory results.
• Create APPX data files and randomisation memos to support data analysis.
• Participate in regulatory audits, departmental initiatives and cross-functional projects.
• Represent Quality Control at relevant project, product and organisational meetings.
• Provide technical guidance and training to colleagues where required.
• Support regulatory filing activities where applicable.
• Maintain personal training requirements and comply with all site safety procedures.
• Identify and drive improvements within the Quality Control function.
• Provide flexibility to support extended hours, weekend work or shift coverage when required.

Skills & Experience

• Bachelor’s degree in Science or another relevant technical discipline.
• Approximately 2–3 years of biopharmaceutical Quality Control, pharmaceutical testing or GMP laboratory experience.
• Practical experience working within a cGMP-regulated analytical laboratory.
• Strong understanding of Good Manufacturing Practices, Data Integrity requirements and regulatory expectations for pharmaceutical testing.
• Hands-on experience with relevant analytical technologies, ideally including:
• HPLC
• Reduced capillary electrophoresis–SDS (rCE-SDS)
• Experience planning and performing routine and non-routine analytical testing.
• Strong analytical, troubleshooting and problem-solving capabilities.
• Ability to interpret qualitative information, quantitative research and analytical trend data.
• Experience reviewing or approving analytical results and laboratory documentation.
• Strong technical writing skills, particularly for investigations, procedures, SOPs and change controls.
• Experience with laboratory investigations and controlled documentation changes.
• Knowledge of LIMS and laboratory data-management processes.
• Ability to identify potential issues and escalate them professionally and promptly.
• Strong written and verbal communication skills, with the ability to engage effectively across different functions and organisational levels.
• Demonstrated ability to work independently, manage competing priorities and consistently deliver right-first-time results.
• Strong teamwork, presentation and coaching skills.
• Experience participating in audits or interacting with regulatory agencies would be advantageous.

Contract Information

• Rate: TBC dependent on level of skills and expertise of the Candidate.
• Start Date: ASAP.
• Location: South Dublin.
• Working Hours: Standard daytime hours, with flexibility for extended hours and occasional weekend work where required.
• Length of Contract: 12 month contract with the possibility of extension.
• Visa Requirements: Candidates must already hold unrestricted eligibility to work in Ireland. Irish/EU citizenship, Stamp 4 and Stamp 1G permissions can be considered.