Easter Seals Jobs

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 (https://twitter.com/abbvieireland) , Facebook, Instagram (https://www.instagram.com/abbvieireland/) , YouTube and LinkedIn.

Job Description

We are currently hiring a Microbiology Quality Laboratory Manager in our Westport site. The Microbiology Manager is responsible for the planning, supervision and control of a Microbiology testing team involved in the microbial analysis of product and raw material testing for commercial, clinical and development batches in line with Abbvie policies and FDA, European and other MOH regulatory requirements. The Microbiology Manager will also be responsible for the microbiology stability testing program and testing associated with new projects.

The Microbiology Manager will be knowledgeable of regulations pertaining to all microbial testing and validation of Sterility, endotoxin, MLT, APET testing, Growth Promotion, antibiotic assay and microbial identifications, and will ensure that the testing procedures is in line with these regulations. The position holder will be responsible in ensuring that the laboratory equipment and validation of testing methods meets regulatory requirements and initiate projects to continuously improve testing equipment and testing methods.

The position holder will ensure a continued “on the floor” presence within the laboratory area, actively engaging with, challenging and motivating team members. The Microbiology Manager is accountable for the activities of Micro Supervisors and technicians within the team they manage. The Microbiology Manager must show the competence the overall management skills to ensure that the Micro function adds to the greater benefit of the facility from a Microbial testing perspective. In association with the Sr Manager Micro and Sr Manager Projects the Microbiology Manager will work to meet company goals and objectives, customer requirements and the regulatory obligations as laid down by the FDA, EU and regional MOH.

Responsibilities

• Provide guidance to direct reports to ensure activities are completed as per schedule and in a GMP compliant manner and in line with regulatory (QA and EHS) and corporate requirements

• Maintain strong relationships with management and colleagues both within the site business units and the quality function, direct reports and customers. Articulate the necessary micro requirements in a clear, concise and persuasive manner.

• Provide motivation to the team and take appropriate corrective action on individual/team performance where required.

• Hold performance meetings according to company policy.

• Update TMS and take appropriate action where an individual’s attendance / timekeeping is below the expected standard.

• Actively participate in the training and certification of new employees.

• Ensure that all aspects of the area of responsibility are fully staffed and that any constraints are managed appropriately.

• Coach and develop team members to support the Company’s succession planning

• Ensure testing is performed as per determined schedules and in line with regulatory requirements

• Ensure effective recording, analysis and reporting of Micro KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.

• Ensure appropriate investigation is performed on out of specification results from testing.

• Ensure timely review of data generated within the team in conjunction with team reviewers.

• Work in conjunction with the laboratory trainer to ensure that sufficient technicians are proficient in the necessary tasks.

• Represent the company in Ministries of Health inspections as deemed necessary as a subject matter expert in the field of Microbiology

• Foster an environment of continuous improvements

Qualifications

• 5+ Years of experience in a QC environment within the pharmaceutical industry

• 2+ years experience managing a team

• Scientific qualification in relevant discipline

• Knowledge of laboratory GMP standards.

• Extensive knowledge of microbiology tasks and associated regulatory standards and guidance. Ability to anticipate, understand and address the changing regulatory environment of the Pharma/Medical Device industry. Assess implications of new regulatory guidance and implement necessary changes as they relate to Micro and aseptics

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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