Purpose

Senior leader in QC laboratory performing, leading, analyzing and/or documenting laboratory tests within a GMP environment in support of one or more of the following areas; raw materials, in-process product, finished product, stability, sterility and/or validation for microbiological processes. Uses scientific education and/or experiences to generate results in accordance with GMP/procedural requirements and scientific principles. Interprets data output to determine conformance with product specifications. Performs trend analyses for assay and product. Reviews and verifies data generated by others to determine conformance with product specifications. 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. Trains other laboratory personnel on any technique they currently have in their training matrix.

Responsibilities:

• Leads and influences analysts in QC with their tasks and activities.

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

• Proposes and implements changes to maintain procedural requirements.

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

• Proposes and implements changes to improve laboratory techniques and methodology.

• Independently troubleshoot and resolve analytical techniques and instrument issues.

• Interprets experimental data for conformance with product/material specifications.

• 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.

• 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:

• Experience with aseptic simulation validations

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

• 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. ​

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. ​

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Abb Vie 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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About Abb Vie

Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.