Senior QC Associate - NPI

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

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.

Skills

Analytical testing

Quality control

GMP knowledge

Regulatory compliance

LIMS data handling

Documentation

Education

Bachelor's degree in science

Tools

LIMS

SOPs

Job description

Senior Associate QC NPI

12-month contract with potential extension. 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

Senior Associate QC NPI

12-month contract with potential extension. 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

Key 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.

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 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.
• 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 contribute to regulatory filings.
• May represent the department/organization on various teams. May train others.
• May interact with outside resources

The successful candidate will:

• 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.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-group.com.