We are looking for the Stability Program Coordinator at our manufacturing site in Clonshaugh.
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.
Job Description
The Stability Program Coordinator is responsible for the administration of the stability program, including creating stability protocols, scheduling stability sample pull points, monitoring environmental stability storage chambers, and placing samples on stability according to the relevant procedures.
The role adheres to all cGMP compliance and regulatory mandates and quality requirements, and complies with SOPs and AbbVie policies and procedures. The Stability Program Coordinator applies skills to recognize and resolve issues that impact efficiency, throughput, quality, and the achievement of performance targets. This position requires safe, compliant, and efficient execution of duties in a team environment. This role reports to the QC Stability Supervisor and may act as deputy as deemed necessary.
Primary duties and responsibilities (other duties may be assigned):
* Write EDOCS stability protocols
* Write and approve LIMs stability protocols
* Perform sample management through LIMS (logging samples, labeling, updating inventory, placing samples in chambers, removing samples, and destruction of samples from completed studies) per the relevant procedure
* Run weekly stability pull schedule per the relevant procedure
* Coordinate sending stability samples to contract testing sites and manage stability data from these sites
* Liaise with contract stability sample storage sites
* Stability room management per the relevant procedure
* Approve stability data with the LIMs system and sign stability reports
* Maintain filing and archiving of stability data
* Evaluate stability trends and prepare reports
* Initiate action or deviation reports for applicable nonconformances
* Write annual stability assessment reports
* Liaise with QA, warehouse, packaging sites and pharma tech group
* Maintain data integrity and ensure compliance with FDA, GLP, cGMP regulations, company SOPs, and ICH guidelines
* Observe escalation processes for issues affecting the stability program
* Author documents ensuring cGMP compliance (e.g., investigations, deviations, change controls, change notices, and SOPs related to the stability program)
* Seek process innovation and continuous process improvements
* Identify and report issues or deviations from accepted standards
* Provide status updates on activities and productivity per defined procedures
* Complete and conform to all training requirements; assist in ongoing training of personnel as appropriate
* Observe safety and compliance procedures and highlight safety concerns to help reduce accidents or near misses
Qualifications
* Bachelor’s Degree in Science or related discipline
* Strong knowledge of LIMS; knowledge of Stability Module is an advantage
* EDOCS experience; Excel, MiniTab or other statistics packages
* Experience in stability testing or stability program administration preferred
* Excellent communication and interpersonal skills, including technical writing
* Strong analytical and problem-solving skills
* Experience in a pharmaceutical manufacturing facility
* Knowledge of cGMP requirements and practices including USP and FDA guidance for the pharmaceutical QC laboratory
* Knowledge of microbiology testing and analysis is a plus
* Knowledge of FDA guidelines on stability requirements is a plus
* Must be flexible and able to handle multiple activities
Additional Information
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, learn more at: https://www.abbvie.com/join-us/reasonable-accommodations.html
Selected locations are listed in the job posting and may be subject to change.
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