Senior Analyst, Laboratory Quality Control

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.

What you do, is what we need. Making a difference begins here. And takes all of us.

Welcome to AbbVie!

We are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work.

 

We are recruiting a Laboratory QC Senior Analyst to join our QC team on site in Ballytivnan, Sligo.

In your role as a Laboratory QC Senior Analyst , you will be responsible for providing an effective and analytical service to the plant ensuring that that products manufactured are tested to specification on time and plant quality and safety goals are met. This position will take responsibility for ensuring the timely testing and release of all raw materials, in-process, finished product, stability and contract testing. The senior analyst position is also responsible for ensuring all activities are carried out per schedule and records are maintained to appropriate requirements, they must also ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained and implementing improved working practices in terms of efficiency, compliance and Right First Time.

What you will do:

• 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 practices 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.
• Instilling a quality culture of Zero, Believe it, Achieve it amongst the laboratory team
• Ensuring that all laboratory test equipment is utilised and maintained correctly.
• 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 CI, BEx and RFT.
• Lead the transfer and validation of 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.
• Lead and support any lab-related investigations.
• Other duties as assigned.

What you will need:

• 3rd level qualification in relevant Science discipline
• Minimum 2 years’ experience in Pharma industry
• Strong knowledge of regulatory requirements
• Must have strong knowledge of HPLC, GC,LCMS, GCMS, Automatic titration, Identification techniques.

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. 

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