Chemistry Supervisor, Laboratory Quality Control

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.

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Job Description

We are now hiring a

QC Analytical Lab Supervisor

to join our team in

Abbvie Ballytivnan, Sligo

You will lead the QC Analytical team and ensure the continued success of the team.

Ensure that technical and systems excellence is maintained in the laboratory by ensuring own skills are maintained, by coaching and training analysts to ensure right first-time behavior and by implementing improved working practices in terms of efficiency, compliance and Right First Time.

Responsibilities

Supervise Daily Laboratory operations, ensuring personnel execute their responsibilities in strict accordance with relevant regulatory guidelines.

Support the weekly and daily production schedules and participate in the daily Tier 1 & 2 meeting.

Ensure Laboratory Documentation and Computerized Systems (LIMS, Empower, LabX) compliance with Data Integrity policies and regulatory requirements.

Supervise the QC Analytical laboratory operations and ensure compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others.

Resolving analytical OOS issues as they arise in a timely manner both through practical work and through solTRAQs / OneTrack systems.

Review of results from Clean & Utilities program (WFI / RO / CS water testing), Product Testing (In process and Final product as required) and Analytical Lab (pH, TOC, Conductivity, Osmolality, Density, HPLC, Raman, etc.) activities, results and raw data on time, accurately and legibly.

Participate actively in Laboratory Investigations Reports (LIRs), Invalid results investigation review, approval and creation of effective CAPAs.

Initiate and Collaborate with all Out of Specification (OOS) results.

Ensuring 6S excellence is maintained across the Laboratory.

Instilling a quality culture of Zero, Believe it, Achieve it amongst the QC laboratory team.

Lead and contribute to project initiatives to improve laboratory operations and efficiency as assigned by the QC Lab Manager, acting as designee for the Laboratory Manager as assigned.

Work with a cross functional team, Supervisors, Quality Manager and Laboratory Manager to ensure compliance with Quality Management System

Support the training and mentoring of laboratory personnel and contribute to training program development.

Operates in an environment which is essentially self-managed but with supervision through the Laboratory Manager.

Provides supervision to direct reports and be responsible for setting annual goals, completing reviews, growth plans and performance management of the team.

Qualifications

BS in science or equivalent (Chemistry, Microbiology, or Biology preferred)

2-5 years of laboratory experience

2-5 years of supervisory experience

Demonstrated skills to deal effectively with members of the department and the areas serviced by the laboratory

Problem solving skills are required

Must be able to interpret impact of laboratory data for appropriate and effective actions

Must be able to identify problem areas requiring development, maintenance, production, engineering, accounting, or planning with assistance from more senior staff

Must also be able to identify, communicate, and follow-through to completion and assist in the development of necessary corrective action plans to resolve the problem with supervision.

May also assist in the activities required for the investigation and resolution

Additional Information

3rd Level Qualification in a Science Discipline, preferably Analytical related.

Job Technical Skills

Minimum 4 years experience in the pharmaceutical industry.

Proven track record in an analytical role.

Must be expert in HPLC, Raman, pH, Osmolality, Conductivity, among others.

Experience with HPLC, Raman and Analytical methods (pH, TOC, Osmolality, Density, among others) preferred.

Experience and good knowledge of SampleManager and Empower systems.

Involvement in product transfers / method transfer, method development experience preferred.

Good knowledge and understanding of Data Integrity from Laboratory perspective.

Preferable knowledge in ADC (Antibody-Drug Conjugate), mAb (Monoclonal Antibodies) and Aseptic process production.

Business Skills

Excellent communication, organization, time-management and teamwork skills

Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures.

Requires total commitment to quality and maintaining a high standard of work at all times.

Demonstrate ability to work on one\'s own initiative.

Strong Problem-solving skills.

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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