QC Analyst
Morgan McKinley View all jobs
- Carlow
- Contract
- Full-time
- Work in line with GMP and regulatory requirements in all day-to-day activities
- Ensure data integrity (ALCOA principles) is maintained across all records and systems
- Support and resolve quality-related queries in collaboration with internal teams
- Escalate any risks that may impact product quality, safety, or compliance
- Contribute to maintaining a strong quality and compliance culture
- Perform analytical and/or microbiological testing to support product release
- Conduct material inspections and testing against specifications
- Maintain a compliant and safe laboratory environment
- Support testing related to biologics or pharmaceutical products
- Support and/or lead activities related to:
- Deviations and investigations
- CAPAs (Corrective and Preventive Actions)
- Change controls
- Validation and material qualification
- Quality risk management
- Review batch records, test data, and quality documentation
- Assist in writing and updating SOPs and controlled documents
- Collaborate with cross-functional teams (e.g. manufacturing, quality, technical)
- Support product release activities and ensure timely delivery
- Assist with continuous improvement initiatives to enhance efficiency and compliance
- Support business-critical projects within the Quality function
- Support internal and external audits and inspections
- Contribute to audit readiness and follow-up actions
- Participate in training and support onboarding of team members where required
- Degree in a scientific discipline (or equivalent experience)
- Experience in a pharmaceutical or regulated environment preferred
- Understanding of GMP and quality systems
- Strong attention to detail and problem-solving skills
- Ability to work collaboratively in a team environment
- Supports day-to-day quality and testing activities
- Assists with audits, validation, and technical transfers
- Applies knowledge to solve routine problems
- Takes greater ownership of quality issues and investigations
- Provides technical guidance and support to others
- Contributes to reporting, metrics, and system improvements
- Handles more complex problems and decision-making
- Site-based role
- May require flexibility to support operational needs (e.g. shift patterns)