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Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$79k–$141k/yr
Full-time
bachelor degree
Paid time off, Vacation, Holidays, Sick leave, Medical insurance, Dental insurance
Posted 11d ago
~40 hrs/week
Responsibilities
The Specialist oversees the plant CAPA Quality System by performing root cause investigations for nonconformities in drug product manufacturing and packaging. They are responsible for leading complex investigations, ensuring regulatory compliance, and promoting a culture of continuous improvement.
Requirements
Candidates must hold a bachelor's degree in Biology, Chemistry, or Engineering and possess at least 6 years of experience in the pharmaceutical industry. Strong analytical skills and a deep understanding of Quality and Compliance regulations are required.
Full job description
Company Description
About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
Job Description
Oversees the plant CAPA Quality System by performing root cause investigations for exceptions/nonconformities/deviations to required procedures and/or specifications for drug product manufacturing and packaging.
Responsibilities
List up to 10 main responsibilities for the job. Include information about the accountability and scope.
Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements
Coordinates the exception document process and creates exception documents
Independently leads complex, high impact investigations
Ensures all investigations are written according to corporate and site requirements
Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System
Ensures all Quality CAPA goals and metrics are met
Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions
Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plant
Qualifications
Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering
6+ years of experience in the pharmaceutical industry in Manufacturing, Quality or Engineering
Demonstrates ability to problem solve and utilize analytical skills
Knowledge of Quality/Compliance management, Regulations and Standards
Additional Information
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.
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.
Allergan is now part of AbbVie.
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.abbvie.com. Follow @AbbVie on LinkedIn for future updates.
Offices: Allergan plc, Dublin, Coolock D17 E400, IE · Morris Corporate Center III, 400 Interpace Parkway, Parsippany, NJ 07054, US · Parkway, Marlow, England SL7 1YL, GB · 301 W Howard Ln, Austin, TX 78753, US · 8301 Mars Dr, Hewitt, TX 76712, US
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