Senior Laboratory Analyst, QC

We are looking for a Senior QC Analyst at our Manufacturing site in Carrigtohill Cork. This is a permanent position and is also a days shift role.

The Senior Laboratory Analyst is responsible for ensuring the effective efficient and compliant operation of daily laboratory activities. Acting as the technical expert within the team the Senior Analyst drives analytical performance assures data integrity supports continuous improvement and serves as a key point of contact for technical problem-solving. Acting as designate for the QC Supervisor the Senior Analyst will focus on technical leadership operational execution and performance accountability within the laboratory environment.

Role & Responsibilities:

1. Technical Expertise & Leadership Serve as the subject matter expert (SME) for laboratory methods instrumentation and analytical techniques. Lead troubleshooting and root cause analysis for technical and analytical issues. Provide guidance and mentorship to analysts on analytical methods calculations and data interpretation. Perform analysis as required to support on time batch release. Assist in the training and mentoring of QC analysts.

2. Operational Excellence Oversee daily analytical operations to ensure testing is executed accurately efficiently and on time. Ensure compliance with GMP GLP and company quality standards in all aspects of lab work. Monitor laboratory workflows identify bottlenecks and proactively drive performance improvements. Support the scheduling and prioritization of testing activities to meet business needs.

3. Data Integrity & Quality Review and approve analytical data calculations and results for accuracy completeness and compliance. Support internal and external audits by maintaining a high state of inspection readiness. Ensure documentation practices (LIMS notebooks electronic systems) meet regulatory and company standards.

4. Continuous Improvement Identify and implement opportunities for process optimization error reduction and efficiency gains. Support implementation of new technologies digital tools or automated solutions. Contribute to laboratory KPIs and performance metrics tracking and improvement initiatives.

5. Collaboration & Support Work closely with the Laboratory Supervisor and Batch release Co-ordinator to align technical and release priorities. Liaise with cross-functional teams (QA Manufacturing Validation R&D) on testing requirements and technical investigations. Provide technical input to deviation investigations CAPAs and change controls. Participation in QC and site projects by representing QC so as to provide an appropriate service to other departments Allocation of work to the QC staff to ensure schedule adherence when required. Delegate for QC Supervisor

6. Analysis of materials: Execute analysis as required to support timely release.

7. Meet the Quality and Safety standards: Ensure QC activities are executed in line in in-house procedures and in compliance with requirements of cGMP. Ensure QC activities are executed in line with safety requirements and good laboratory practice. Keep work area clean and tidy. Keep up to date on regulatory development and standards by accessing in house library accessing current Pharmacopoeias etc. Participation in investigations into failures out of trends and out of specifications as required ensuring follow up following anomalies failures and external compliance ensuring corrective actions are implemented

8. Reporting and communication: By reporting and communication to QC supervisor and or manager in timely fashion any events or incidents. By participation in preparation of QC reports. By completing checking of data to ensure accuracy and compliance Review analytical data and approve and release material as defined in relevant procedures. Maintaining an awareness of technical developments in instrumentation analysis Complete documentation reviews reports preparation and trending activities to ensure compliance Use internal audits to check that rules are applied propose corrective actions and ensure that they are applied

Qualifications :

• Degree in an analytical science is preferred
• Minimum 3 years experience in a laboratory environment. Direct experience of HPLC analysis would be an advantage
• Analytical approach to tasks. Good organisation skills. Technical skills in analysis are important. Knowledge of QC regulations. Knowledge of EU and FDA regulations. Good organisational and time management skills Excel; Word
• English - Fluent

Additional Information :

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time