Principal Scientist, QC Laboratory Program

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.

Purpose

The position manages aspects of the quality control (QC) data trending of the testing results. The incumbent is responsible to assess the QC data and identify any trend that could lead for Compliance and continuous improvement of the laboratory performance. Ensure that QC sections of the annual product quality review documentation are in compliance with regulations and policies. Work cross functionally to solve problems and implement any corrective action to improve laboratory performance. Gather, analyze and trend QC data results in the laboratory including release testing, reference standard performance, quarterly reports, etc.

Responsibilities

• Lead all QC trending program such as release data (in house, TPM and CMO) including current and new process changes. Implement any corrective action that include QC data gathering and analysis, best practice research and implementations, recommending alternatives for improvement, developing performance metrics, obtaining leadership or stakeholder agreement and implementing improvements.
• Support organizational goals and are accountable for providing solutions to improve laboratory performance and internal /external customer expectations. May utilize Lean/Six Sigma processes and concepts for improvement initiatives.
• Defines, develops and evaluates performance metrics to improve people performance, and will perform evaluation of all laboratory investigations as independent reviewer to ensure the corrective actions are appropriate to fix the problem and aligned with laboratory improvement vision. Participate and work with multiple stakeholders, often with competing/conflicting objectives, to ensure interconnected and reachable measures of success.
• Generate MEC monthly and quarterly reports and analyze the data in conjunction with MEC personnel, lead the reference standard, lead the QC track and trending program ensuring the investigations for alert and action rule violations are investigated properly and ensure the corrective actions are appropriate to address the rule excursion.
• Lead and manage QC training area assessing training modules are aligned with policies, improvements and laboratory needs. Constantly assess training matrix of all laboratory personnel to ensure consistency and compliance of the module and training requirements.
• Prepare presentations to the management at establishes frequencies (e.g. monthly, quarterly) such as PIT and management review and keep track of the program.

Qualifications

• Minimum 8 Years’ of experience in quality or related field within the Pharmaceutical or Biotechnology industry.
• Project Management experience is a plus.

• Knowledge of regulations and standards affecting Pharmaceutical Products, i.e., CFR210/211, CGMP’s, DEA, EP, JP, and USP.
• Must have a basic understanding and working knowledge of physical and chemical characteristics of the products manufactured at ABL.
• Knowledge of statistical quality systems.
• Knowledgeable on GMP and other regulatory requirements. The incumbent must be able to undertake scientific discussion. 
• Must be fluent in Spanish and English, both oral and written. Possess excellent communication and negotiation skills.

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

• The compensation range described below is the range of possible base pay compensation that theCompany believes in good faith it will pay for this role at the time of this posting based on the job gradefor this position. Individual compensation paid within this range will depend on many factors includinggeographic location, and we may ultimately pay more or less than the posted range. This range may bemodified 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 otherform of compensation and benefits that are allocable to a particular employee remains in the Company'ssole and absolute discretion unless and until paid and may be modified at the Company’s sole andabsolute discretion, consistent with applicable law. 

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

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