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QC Analyst
Carlow Contract Competitive
About the job
QC Analyst - 11 months
(Weekend shift role)
This role sits within the Quality function and is responsible for supporting laboratory testing, quality systems, and compliance activities in a regulated pharmaceutical environment.
The position plays a key role in ensuring products are tested, reviewed, and released in line with regulatory requirements, quality standards, and business needs.
Key Responsibilities
Quality & Compliance
- 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
Laboratory & Testing
- 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
Quality Systems
- 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
Operations & Delivery
- 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
Audits & Training
- 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
Experience & Background
- 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
Level Differences
O3 Level
- Supports day-to-day quality and testing activities
- Assists with audits, validation, and technical transfers
- Applies knowledge to solve routine problems
O4 Level
- 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
Additional Information
- Site-based role
- May require flexibility to support operational needs (e.g. shift patterns)
