Job Details

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 (https://www.tiktok.com/@abbvie) .

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Sr. Stability Technician monitors and analyzes data reports for accuracy and adverse trending identification as well as data compliance and consistency. Manages laboratory systems and other tools as required. In addition handles multiple priorities and delivers tasks/projects in a timely manner. Must comply with all security guidelines, Environmental Health and Safety regulations and current Good Manufacturing Practices required.

Responsibilities

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Reconcile data authorization and ensure it is done in compliance with stability procedures and maintain direct communication with personnel in charge of data authorization. By doing this, the Sr. Stability Technician will be a direct link between verifier and supervisor while optimizing the stability program. This will include all testing performed on the samples, considering communication with different areas like the Analytical and Microbiology Labs.

• Preparation of all required documentation for sample shipments to Out labs (Pre-shipments).

• Performing Stability Pulls and monthly reconciliation of future Stability Pulls with the preparation of reports within the program’s system.

• Generate reports for the stability data using electronic system and manual reports to comply with regulatory requirements and regional specifications.

• Organization of sample inventory and verification of all required documentation ensuring compliance with local procedures and regulatory requirements. This will include the handling of materials used within the stability program (samples in the long term storage (chambers), in process samples and reference standards use for testing).

• Perform “5S” audits and internal audits in the laboratory, recognizing areas for improvement and making sure the laboratory is in compliance in every moment.

• Documentation of required forms to retrieve equipment from the alarm reporting system, thus accelerating the process of the equipment repairs.

• Create studies within Sample Manager LIMS 11 system to support the stability requirement for annual commitment and validation activities.Reference Standard Receipt and documentation. Maintain logbook documentation organized and without discrepancies.

• Frequent to continuous computer usage (greater or equal to 50% of the workday) is required

• Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

Qualifications

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Associates Degree in Science with a concentration in Biology or Chemistry preferably.

• Excellent verbal and written communication skills, English and Spanish.

• Manage request projects with minimum supervision.

• Experience in document control and Data analysis – Minimum one (1) years

• Basic knowledge of laboratory practices like pH, Appearance, Electrophoresis, HPLC, ELISA among others.

• Computer knowledge such as Microsoft Word, Power Point, Excel, etc.

• Basic knowledge in statistics tools such as mean, standard deviation and relative standard deviation for populations. LIMS System experience is preferably.

Key Stakeholders

Interact with Regulatory Affairs, Third Parties, Clients and Counterparts inside and outside the plant.

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. ?

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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 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

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html