Maintenance Technician

PE Global (UK); Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading biotech company in County Cork is seeking a Sr QC Associate to manage quality control activities. The role includes analytical testing and supporting QC and manufacturing operations, requiring candidates with a Bachelor's degree in a science discipline and 2-3 years of relevant experience. The position may involve extended hours and weekend work as needed, focusing on regulatory compliance and various quality control tasks.

Qualifications

• 2-3 years of biopharmaceutical QC experience or related quality control or GMP laboratory experience.
• Strong background in Chemistry and Analytical testing required.
• Understanding of principles and standards of GMP QC analytical laboratories.

Responsibilities

• Responsible for various activities in QC including analytical testing and data management.
• Plan and perform analyses efficiently and accurately.
• Participate in audits, initiatives, and projects.

Skills

Analytical testing

Problem-solving

Regulatory compliance

Team collaboration

Education

Bachelor’s degree in a science discipline

Job description

Description

PE Global is currently recruiting for a Sr QC Associate on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Job Summary

• Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team
• This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Responsibilities

• 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.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance.
• May train others.

Education and Experience

• 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 or medical device industry.
• Strong background in Chemistry and Analytical testing is required.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
• Understanding and application of principles, concepts, theories, and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning

Apply

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to [e-mail]

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***