Senior QC Analyst: Elevate Lab Integrity & Compliance

AbbVie Inc.; Sligo; On-site; EUR 55,000 - 75,000; Full time

Job summary

AbbVie is recruiting a Senior QC Analyst to join the QC team on site in Ballytivnan, Sligo on a perm contract. This day shift role requires ensuring data integrity, regulatory compliance, timely lab analysis, and team coaching to maintain high performance.

The role involves leading transfer and validation of analytical methods, improving practices, maintaining records, and developing training materials for QC analysts within a robust quality system.

Qualifications

• 3rd level qualification in the relevant science discipline.
• 4-5 years’ experience in a similar role within the pharmaceutical industry.
• Proven track record in an analytical role.

Responsibilities

• Ensuring Analytical Laboratory Documentation and Computerized Systems compliance with Data Integrity policies and regulatory requirements.
• Understanding Regulations and business processes required to maintain Laboratory Data Integrity.
• Ensuring timely completion of all laboratory analysis assigned to shift.
• Ensuring that analysts working in the assigned cell or team are performing to the best of their ability, coaching and providing guidance where issues occur such as poor set-up or test execution performance.
• Improving the overall efficiency and velocity within the assigned team.
• Identifying and implementing improvements in analytical practice using 'Zero, Believe it, Achieve it'
• Ensuring that the agreed test schedule is adhered to and identifying recovery paths to bring test schedules back into alignment with plant requirements.
• Identifying weaknesses in laboratory performance and working with the laboratory management to rectify.
• Supporting & initiating analytical OOS issues as they arise in a timely manner both through practical work and through the quality system.
• Ensuring 5S excellence is maintained across the Laboratory.
• Executing and / or supporting projects through the Lab Management team.
• Maintaining up-to-date, complete and precise records of all tests performed.
• Developing expertise and understanding of current and future analytical techniques.
• Developing and updating of in-house laboratory procedures as appropriate.
• Carrying out verification of testing records & generation of Final CoA as necessary.
• Positively contribute to departmental programs such as e-ACHIEVEs, and iCANs
• Lead the transfer and validation of NPI analytical test methods to the QC Laboratory.
• Lead validation of equipment for the QC Laboratory.
• Adhere to and support all EHS & E standards, procedures and policies.
• Development of training material and the training of QC analysts.
• Lead and support any lab-related investigations.

Education

3rd level qualification in the relevant science discipline

Job description

AbbVie is recruiting a Senior QC Analyst to join the QC team on site in Ballytivnan, Sligo on a perm contract. This day shift role requires ensuring data integrity, regulatory compliance, timely lab analysis, and team coaching to maintain high performance.

The role involves leading transfer and validation of analytical methods, improving practices, maintaining records, and developing training materials for QC analysts within a robust quality system.