Microbiology Supervisor, Laboratory

Company 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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

We are now hiring a QC Micro Lab Supervisor to join our team in Abbvie Ballytivnan, Sligo. You will lead the QC Microbiology 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.

A snapshot of your key 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 & LabX) compliance with Data Integrity policies and regulatory requirements.
• Supervise the microbiology laboratory operations and ensure compliance with regulations including EU Annex 1, ISO, WHO, FDA Guidelines for Aseptic Processing, among others.
• 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.
• Review results of Clean & Utilities program (WFI/RO/CS water testing), Product Testing (In process and Final product) and Environmental Monitoring activities, results and raw data on time, accurately and legibly.
• Knowledge about Bioburden, Endotoxin and analytical testing (pH, TOC, Osmolality, Density, among others)
• Participate actively in Laboratory Investigations Reports (LIRs), Environmental Monitoring Investigations, review, approval and creation of effective CAPAs. Initiate and Collaborate with all Out of Specification (OOS) results.
• Maintain a clean, safe, and well-organized laboratory environment.
• 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 of 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

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

Job Technical Skills

• Minimum 4 years microbiology experience in the pharmaceutical industry.
• Experience with Bioburden, Endotoxin, Environmental Monitoring and Analytical methods (pH, TOC, Osmolality, Density, among others) preferred.
• Experience and good knowledge of SampleManager systems.
• Involvement in product transfers / method transfer, method development experience preferred.
• Preferable knowledge in ADC (Antibody-Drug Conjugate), mAb (Monoclonal Antibodies) and Aseptic process production.

Business Skills

• Good knowledge and understanding of Data Integrity from Laboratory perspective.
• 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.
• Demonstrate ability to work on one’s own initiative.
• Strong Problem-solving skills.
• Strong people management skills.

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. 

• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
• https://www.abbvie.com/join-us/reasonable-accommodations.html