NPI QC Specialist: Analytical Testing & Data Lead

Berkley Group

Dublin

On-site

EUR 50,000 - 70,000

Full time

35 hours ago

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Job summary

Berkley Life Science & Engineering is seeking a Senior Associate QC NPI for a 12-month contract in Ireland. Under minimal supervision, you will handle analytical testing, characterization, sample and data management within QC for NPI activities and related site projects.

You will create and review protocols, manage sample plans, support method transfers and validation, and contribute to regulatory filings. The candidate will hold a science degree and 2–3 years of biopharmaceutical QC experience

Qualifications

Bachelor's degree in a science discipline.
2-3 years of biopharmaceutical QC experience or related GMP laboratory experience.
Strong background in Chemistry and Analytical testing is required.
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
Experience with data management and documentation.

Responsibilities

QC Representative for NPI activities and routine Product meetings.
Assist with activities related to QC projects and/or QC tasks within Site projects.
Plan and perform non-core testing related to NPI activities.
Manage all sample management activities related to NPI activities throughout the site.
Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
QC Representative responsible for Method Validation and Transfers co-ordination and readiness.
Responsible for their own training and safety compliance.
Sample shipments and temperature monitoring activities for NPI activities.
LIMS data coordination of non-core (NPI) activities.