QC Compliance Specialist ( 12 month FTC)
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Cork, CO
- Operations
- On-Site
- Full-time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
We are currently looking for a QC Compliance Specialist at our manufacturing site in Cork , this is a 12 month FTC role.
The QC Compliance Specialist is responsible for ensuring quality assurance processes and safety protocols are consistently followed within the laboratory environment. This position ensures the QC laboratory maintains the highest standards of quality and safety, supporting both regulatory compliance and continuous process improvement.
Role & Responsibilities:
- Monitor and ensure compliance with laboratory quality control procedures and safety guidelines.
- Lead the Laboratory Compliance and Safety Walkdown programmes to ensure compliance with internal and external regulations.
- Lab Investigation writer
- Implement effective CAPA
- Generation of QC department PQR reports on a biannual basis in line with site PQR schedule
- Support QC department audit readiness for internal and external inspections.
- Collaborate with management and other departments to improve lab processes and resolve compliance issues.
- Prepare compliance reports, SOPs, and maintain accurate records.
- Participate in risk assessments and hazard analyses.
- Identify and support Continuous Improvement activities within the QC department
- Support QC Snr Support Analyst through Compliance Wire administration and onboarding training as needed
- QC Department Safety lead on site Green Button (safety) Team
- Lead QC safety team to drive lab safety improvements
- Primary degree in analytical science or in an equivalent science-based discipline
- 3 years minimum experience in pharmaceutical quality control laboratory. Experience of Trackwise and applicable modules ER, CP and audit an advantage.
- Knowledge of QC regulations, European and FDA regulations
- Experience with QC analytical methods and procedures
- Knowledge of QC equipment and data integrity principles
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Pay Range: $
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Where We Work
Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.