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In this role you will provide an effective testing and analytical service to the Abbvie Ballytivnan Biologics business, ensuring that conjugate biological products manufactured are tested to specification on time and Abbvie Ballytivnan Biologics plant quality and safety goals are met.

You will also take responsibility for ensuring the timely testing and release of all aspects of our conjugation manufacture including in-process, finished product, stability and contract testing, while also 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.

Key Responsibilities include, but are not limited to;

Ensuring 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 6S 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 changing 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.
Supports the transfer of new products to the QC Laboratory.

Qualifications

So, what do you need to do this role?

You will have a 3rd level qualification in a relevant Science discipline.
Minimum 2 years analytical experience in the pharmaceutical industry.
Proven track record in an analytical role. Must be expert in HPLC, GC, and Identification techniques.
Strong knowledge on regulatory requirements.
Proficient in using analytical equipment in a QC lab.