Associate Quality Control

Recruitment by Aphex; Ireland; On-site; EUR 55,000 - 85,000; Full time

Job summary

Aphex Group in Ireland is seeking a Quality Control NPI Senior Associate to support analytical testing, data management and sample control for NPI projects. You will contribute to QC, Process Development and manufacturing operations, ensuring GMP compliance.

With 2–3 years of biopharma QC or related GMP lab experience, you will coordinate LIMS data, develop sample plans, and assist in regulatory filings and documentation. Training and safety compliance are essential in this role.

Qualifications

• Bachelor's degree in a science discipline.
• 2-3 years biopharmaceutical QC or related GMP lab experience.
• Demonstrated experience with GMP, Data Integrity and analytical technologies (HPLC, rCE-SDS, Sub-Vis Particles, Protein Concentration/Protein Content).

Responsibilities

• QC Representative for NPI activities and routine Product meetings.
• Assist with activities related to QC projects and/or QC tasks within Site projects.
• Manage all sample management activities related to NPI activities throughout the site.
• Create/own sample plans, SOPs and documentation related to NPI.
• Responsible for training and safety compliance.
• LIMS data coordination of non-core (NPI) activities.

Skills

GMP QC

Data Integrity

Analytical testing

HPLC

Problem solving

Biopharma QC

Education

Bachelor's degree in science

Tools

LIMS

Job description

Quality Control NPI Snr Associate

Purpose

Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterisation, sample and data management. Contributes to the completion of milestones associated with specific projects or activities within team. This role will support QC, Process Development and manufacturing operations.

Responsibilities:

• QC Representative for NPI activities and routine Product meetings
• Assist with activities related to QC projects and/or QC tasks within Site projects
• Manage all sample management activities related to NPI activities throughout the site
• Create/own sample plans, SOP's and documentation related to NPI
• Responsible for their own training and safety compliance.
• LIMS data coordination of non-core (NPI) activities.

Specific Job Duties:

• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform analyses with great efficiency and accuracy.
• Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
• Report, evaluate, back-up/archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organisational in scope.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• May provide technical guidance. May contribute to regulatory filings.
• May represent the department/organization on various meeting forums
• May interact with outside resources

Basic Qualifications & Experience:

Qualifications

• Bachelor's degree in a science discipline.
• 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical
• Professional requirements: Demonstrated experience with current Good Manufacturing Practices, Data Integrity and sound analytical technologies (HPLC, rCE-SDS, Sub-Vis Particles, Protein Concentration/Protein Content)
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Knowledge:

• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
• Strong analytical ability and associated problem solving.
• Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery