Senior Associate QC / NPI

Berkley Group; Dublin; On-site; EUR 50,000 - 70,000; Full time

Job summary

Berkley Group in Dublin, Ireland seeks a Quality Control NPI Senior Associate to support QC, Process Development and manufacturing operations. The role involves analytical testing, data management, and contributing to audits and initiatives.

The candidate should have a science degree with 2–3 years of biopharmaceutical QC or GMP lab experience, and familiarity with GMP, Data Integrity and analytical tech like HPLC and rCE-SDS.

Qualifications

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

Responsibilities

• 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 organizational 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.

Skills

GMP compliance knowledge

Data integrity awareness

Analytical thinking

Education

Bachelor's degree in a science discipline

Tools

HPLC

rCE-SDS

Sub-Visible Particles

Protein concentration / protein content

cGMP testing

Job description

Global Biotechnology company, based in south Dublin, Ireland - looking for Quality Control NPI Senior Associate.

The successful candidates will be responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.

This role will support QC, Process Development and manufacturing operations, as such some extended hours, weekend work flexibility and shift work may be necessary as required.

The role:

• 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 organizational 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.

Have You:

• 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.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.