QC Senior Specialist

AbbVie; Sligo; On-site; EUR 65,000 - 85,000; Full time

Job summary

AbbVie in Ballytivnan, Sligo, seeks a QC Senior Specialist to join the Quality Control team. You will report to the QC Lab Manager and act as the SME for the analytical lab, guiding cross-functional teams and ensuring the lab remains compliant with data integrity policies and regulatory requirements.

You will transfer and validate analytical methods, qualify new equipment, manage documentation, lead OOS investigations and CAPA, and develop training materials for QC analysts, contributing to

Qualifications

• At least 5 years of analytical experience in the pharmaceutical industry.
• A third-level qualification in a relevant science discipline.
• Experience in a GLP/GMP environment and knowledge of current cGMP and EU/FDA/ICH/HPRA guidelines.
• SME-level knowledge of HPLC, Identification, Conductivity, Protein Concentration, Osmolality and pH.

Responsibilities

• Support the transfer and validation of analytical test methods.
• Implement and qualify new laboratory equipment, and ensure existing equipment is maintained.
• Ensure laboratory documentation and computerised systems comply with data integrity policies and regulatory requirements.
• Provide technical input for the lab's analytical work during regulatory inspections, ensuring full compliance.
• Review pharmacopoeia requirements and develop in-house lab procedures to meet them.
• Generate and manage analytical technical reports and oversee CAPA actions.

Skills

Analytical experience

QC expertise

Cross-functional collaboration

Education

BSc / MSc in science

Tools

HPLC

Lab equipment

Job description

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.

Job Description

We're looking for a QC Senior Specialist to join our Quality Control team in Ballytivnan in Sligo. You'll report to the QC Lab Manager and be the technical subject matter expert (SME) for the QC laboratory. You'll also be the main contact for any issues in the analytical lab. You'll mostly manage your own work, with a high level of autonomy and no direct reports. You'll give technical guidance across the site, work with cross-functional teams and people at all levels, and help make sure the lab stays fully compliant.

Responsibilities

• Support the transfer and validation of analytical test methods.
• Implement and qualify new laboratory equipment, and make sure existing equipment is maintained according to the procedures that govern it.
• Make sure laboratory documentation and computerised systems comply with data integrity policies and regulatory requirements.
• Provide technical input for the lab's analytical work during regulatory inspections, so the lab stays fully compliant at all times.
• Review pharmacopoeia requirements on an ongoing basis, and develop and update in-house lab procedures to meet them.
• Generate and manage all analytical technical reports.
• Manage the lab's change management process, and oversee CAPA actions so they're completed on time.
• Lead analytical OOS issues and lab-related investigations, so normal lab activities resume quickly with minimal disruption.
• Handle day-to-day issues in Quality Control.
• Identify weaknesses in lab performance and work with lab management to fix them.
• Carry out or support projects as directed by lab management, including cross-functional and cost improvement projects.
• Give the site technical guidance on analytical issues, and bring technical expertise to cross-functional teams.
• Develop training material and train QC analysts. Provide cross-training and guidance on technical analytical methods to new and existing team members.
• Build your expertise in current and future analytical techniques.
• Contribute positively to departmental programmes.
• Comply with all EHS policies, procedures and standards. This includes reporting incidents and near misses straight away, suggesting EHS improvements, attending required EHS training and medical surveillance, and wearing PPE as required.
• Other duties as assigned.

Qualifications

• At least 5 years of analytical experience in the pharmaceutical industry.
• A third-level qualification in a relevant science discipline.
• Previous industry experience, with a proven track record in an analytical role.
• Experience in a GLP/GMP environment, and knowledge of current cGMP and EU/FDA/ICH/HPRA guidelines.
• A high level of expertise in analytical equipment, processes and current best practices.
• SME-level knowledge of HPLC, Identification, Conductivity, Protein Concentration, Osmolality and pH.

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.