QC Microbiology Expansion Lead

Berkley Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Berkley Group is seeking a QC Micro Manager for its south Dublin site to oversee microbiology readiness activities as the site expands its manufacturing operations.

The role focuses on establishing people, processes and laboratory capabilities, working with QC, Quality, Manufacturing and Engineering to ensure microbiology requirements are planned and implemented in line with GMP standards.

Qualifications

• Bachelor's degree in a Science-related field is required.
• 6+ years of bio-pharmaceutical QC experience, or related Quality Control/GMP laboratory experience in pharma/medical devices.
• Experience in a regulated cGMP manufacturing and/or testing environment.

Responsibilities

• Support planning and implementation of QC Microbiology activities for site expansion.
• Lead and coordinate QC Microbiology readiness activities for future operations.
• Assist in development, review, and implementation of GMP documentation (procedures, protocols, reports).
• Support definition, procurement, qualification and implementation of microbiology lab equipment, consumables and media.
• Plan resource, training and qualification to prepare QC Microbiology personnel.
• Provide microbiology input into cross-functional project activities and represent QC Microbiology.
• Collaborate with Quality, Manufacturing, Engineering and others to integrate microbiology requirements into plans.
• Contribute to Environmental Monitoring and other microbiological testing programs as applicable.
• Supervise and coach QC Microbiology staff as required.

Skills

QC Microbiology

GMP compliance

Leadership

Project coordination

Education

Bachelor's degree in science

Job description

Berkley Group is seeking a QC Micro Manager for its south Dublin site to oversee microbiology readiness activities as the site expands its manufacturing operations.

The role focuses on establishing people, processes and laboratory capabilities, working with QC, Quality, Manufacturing and Engineering to ensure microbiology requirements are planned and implemented in line with GMP standards.