Quality Control Associate

Recruitment by Aphex; Dublin; On-site; EUR 45,000 - 65,000; Full time

Job summary

Recruitment by Aphex is seeking an experienced QC Associate with strong microbiology expertise to support biopharmaceutical QC testing and regulatory compliance in a cGMP environment. The role focuses on endotoxin, bioburden and sterility testing, with extensive documentation, reporting, and data trend analysis.

The successful candidate will perform analytical testing with accuracy, participate in audits, develop protocols, and help drive continuous improvement across lab activities in a

Qualifications

• Biopharmaceutical QC experience in a microbiology lab.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

Responsibilities

• Endotoxin testing of water, in-process and drug product release samples.
• Bioburden testing of water & in-process drug product samples.
• Sterility testing.
• Lab support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports.
• Media fill reconciliation and inspection.
• Perform analytical testing as a main priority with efficiency and accuracy.
• With a high degree of technical flexibility, work across diverse areas within the lab.
• Plan and perform multiple routine/non-routine methods and procedures with a large variety of assays.
• Report, evaluate, archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organisational in scope.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Review and Approve lab results
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organisation on various teams
• May interact with outside resources

Skills

Biopharmaceutical QC experience

Regulatory compliance

cGMP familiarity

Analytical testing

Job description

Purpose

Under minimal supervision, successful candidate would be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing. The successful candidate would contribute to team by ensuring the quality of the tasks/services provided by self and contribute to the completion of milestones associated with specific projects or activities within team. This role will support manufacturing operations, as such some extended hours, shift and weekend work may be necessary as required.

Responsibilities

• Endotoxin testing of water, in-process and drug product release samples
• Bioburden testing of water & in-process drug product samples
• Sterility testing
• Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave.
• Writing technical reports
• Media fill reconciliation and inspection
• Perform analytical testing as a main priority with efficiency and accuracy
• With a high degree of technical flexibility, work across diverse areas within the lab
• Plan and perform multiple routine/ non-routine methods and procedures with a large variety of assays.
• Report, evaluate, archive, trend and approve analytical data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives, and projects that may be departmental or organisational in scope.
• Write protocols and perform assay validation.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
• Review and Approve lab results
• May participate in lab investigations.
• May provide technical guidance.
• May train others.
• May contribute to regulatory filings.
• May represent the department/organisation on various teams
• May interact with outside resources

Basic Qualifications:

• Biopharmaceutical QC experience in a microbiology lab
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products