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Senior leader in QC Microbiology laboratory leading and analyzing laboratory test results within a GMP environment in support of the QC Micro Lab and Manufacturing to ensure a deep understanding of plant flora, controls, and risks, in compliance with Regulatory requirements and Network Best Practices. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Works cross functionally, and with varying organizational levels, locally, on Global network teams, and Centers of Excellence groups such as Aseptic Processing and Microbiology Lab. Interprets data output to determine conformance with environmental, personnel and product microbial monitoring requirements/specifications and performs trend analyses. Reviews and verifies data generated by others to determine conformance with product specifications and drive continuous improvement. Understands internal business process, to make appropriate prioritization of their assigned work duties and duties of others in the lab. Has experience and command of multiple laboratory techniques to perform them with minimal error. This role is crucial in driving performance and implementing best-in-class aseptic techniques in QC Micro and Operations, particularly through training and mentorship.  

Responsibilities

•Leads and influences analysts in QC with their tasks and activities by providing on-the-floor support for both manufacturing and laboratory operations, ensuring adherence to safety rules, aseptic techniques and microbiological controls including troubleshooting and resolving microbiological issues in real-time to support uninterrupted production.

•Understands, implements, and maintains GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.

• Develop and implement strategies to drive performance while maintaining best-in-class aseptic techniques in QC Micro and Operations.

•Performs, leads, analyzes and/or documents analytical test methods as written to support product/material release with minimal error.

•Track and trend microbiological performance data and collaborate with cross-functional teams to investigate and resolve microbiological issues and deviations to identify root causes, implementing corrective actions, and prevent recurrence through continuous improvement initiatives.

•Understands and identifies laboratory technique or instrumental performance in accordance with scientific principles.

•Initiates appropriate exception documents in accordance with procedural requirements.

•Implements and ensures improvement ideas are completed to facilitate team objectives. Proposes and implements scientific protocols to determine exception event cause

Qualifications:

•Required - BS degree in Science or equivalent
•10+ years of relevant experience
•Maintains their certifications as needed for assigned job tasks.
•Demonstrates strong analytical skills and logical thought process.

.Preferred Qualifications:

• MS degree in Microbiology
• In-depth knowledge of microbiological techniques, aseptic processing, and environmental monitoring.
• Strong understanding of regulatory requirements and industry guidelines related to microbiology and aseptic processing.
• Strong communication skills, both written and verbal, to effectively communicate findings and recommendations to stakeholders at all levels.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.​

  
  

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

  
  

• This job is eligible to participate in our short-term incentive programs. ​

  
  

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. 

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