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 looking for a Micro Quality Labs Supervisor to join our team on our Westport site for a 12 month contract.
The Supervisor, Quality Labs, Micro is responsible for the planning, supervision and control of a Microbiology environmental or testing teams 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 Supervisor, Quality Labs, Micro will be knowledgeable of regulations pertaining to all microbial testing including Sterility, endotoxin, MLT, APET testing, Growth Promotion, antibiotic assay, environmental monitoring and microbial identifications, and will ensure that the testing procedures is in line with these regulations. The position holder will ensure a continued “on the floor” presence within the laboratory area, actively engaging with, challenging and motivating team members. The Supervisor, Quality Labs, Micro is accountable for the activities of the technicians within the team they manage.
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 aseptic and 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 planningRepresent the company in Ministries of Health inspections as deemed necessary as a subject matter expert in the field of MicrobiologyFoster an environment of continuous improvements for the QC area by identifying and implementing efficiencies and quality improvements.Lead all new product introductions from a microbiology perspective, including but now limited to method validation, validation of cleanrooms, laboratory equipment validations, maintenance and calibration of business unit cleanroom monitoring system.Qualifications
3 Years of experience in a QC environment within the pharmaceutical industrySupervisory experience or demonstrated attributes for people managementScientific qualification in relevant disciplineKnowledge 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.Ability to articulate clearly when dealing with external bodiesExcellent conflict handling skills
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.
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