Quality Assurance Specialist - Evening Shift

Collins McNicholas Group; Sligo; On-site; EUR 65,000 - 75,000; Full time

Job summary

Collins McNicholas Group in Sligo is seeking a QA Specialist for an evening shift at a life sciences site. The role provides hands-on quality support to Operations, ensuring GMP/compliance through batch review, investigations, change control, and process improvement.

Key duties include managing QMS activities, reviewing batch records, and guiding Operations on GMP, manufacturing, validation, and NPI while maintaining regulatory compliance and leading QA activities across cross-functional teams.

Qualifications

• Minimum 5 years’ experience in a GMP Quality environment.
• Strong knowledge of QMS processes.
• Experience with batch documentation, root cause investigations, change control and process improvement.
• Able to work independently and effectively within a team.

Responsibilities

• Manage QMS activities, including deviations, change control, CAPA, audits, complaints and vendors.
• Review and approve batch records, materials and QC testing.
• Provide QA guidance to Operations on GMP, manufacturing, validation and NPI.
• Ensure GMP and regulatory compliance across manufacturing activities.
• Approve SOPs and quality documentation.
• Support batch release, technology transfer and NPI timelines.
• Apply Quality Risk Management principles.
• Lead QA activities across cross-functional teams.

Skills

QA

GMP

QMS

Batch documentation

Investigations

Change control

Process improvement

Team player

Education

Third-level qualification in science/engineering

Job description

Excellent opportunity for a QA Specialist to join a Life Sciences company in Sligo on an evening shift. The QA Specialist provides hands-on quality support to Operations, ensuring GMP and regulatory compliance through batch review, investigations, change control and process improvement.

Overview of your responsibilities

• Manage QMS activities, including deviations, change control, CAPA, audits, complaints and vendors.
• Review and approve batch records, materials and QC testing.
• Provide QA guidance to Operations on GMP, manufacturing, validation and NPI.
• Ensure GMP and regulatory compliance across manufacturing activities.
• Approve SOPs and quality documentation.
• Support batch release, technology transfer and NPI timelines.
• Apply Quality Risk Management principles.
• Lead QA activities across cross-functional teams.

Knowledge, Skills and Experience Required for the Role

• Third-level qualification in a relevant science or engineering discipline.
• Strong knowledge of QMS processes.
• Minimum 5 years’ experience in a GMP Quality environment.
• Experience with batch documentation, root cause investigations, change control and process improvement.
• Able to work independently and effectively within a team.

For a confidential discussion and more information on the role contact Courtney Russell

[e-mail]

[phone]