QA Specialist

Allergan; Greenlawn (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Systems Specialist to support their Global Commercial Distribution and Quality Project Management Office. The role involves maintaining quality management systems, ensuring compliance, and managing quality processes. Candidates should have a Bachelor's degree in a relevant field and experience in quality systems within the pharmaceutical sector. This position offers an opportunity to drive continuous improvement initiatives and ensure regulatory compliance.

Qualifications

• Minimum of 3 years of experience in quality systems within the pharmaceutical industry.
• Experience in a GMP environment.

Responsibilities

• Assist in managing the CDQ Project Management Office.
• Monitor project progress and track milestones.
• Conduct gap analyses and implement corrective actions.

Skills

Quality Systems

Project Management

Regulatory Compliance

Education

Bachelor’s degree in engineering, Science or related technical/scientific field

Tools

Document Control Systems

Job description

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 atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Quality Systems Specialist at AbbVie will support the Global Commercial Distribution and Quality (CDQ) Project Management Office and the CDQ Compliance department by maintaining and improving the quality management system (QMS) to ensure compliance with regulatory requirements and industry standards.

This role involves both managing quality processes, documentation, and systems within the CDQ Compliance Department and Global CDQ PMO.

Primary duties and responsibilities of the position are as follows; other duties may be assigned.

1. Assist in the Management of the CDQ Project Management Office:

• Prepare, facilitate, and follow up on monthly and on-demand Project Review Board (PRB) meetings.
• Assist in the continuous improvement the PMO process according to Commercial Distribution Quality needs and business priorities.

2. Monitor Project Progress:

• Ensure alignment of projects with CDQ long-term goals.
• Track and report on project milestones and deliverables.

3. Develop Project Plans:

• Assist in the creation of project plans, timelines, and budgets for CDQ projects when required.
• Collaborate with stakeholders to ensure project objectives are met.

4. Conduct Gap Analyses:

• Identify gaps in quality processes and implement corrective actions.
• Participate in continuous improvement initiatives.

5. Training and Compliance:

• Ensure all employees within the CDQ Compliance Department and Global CDQ PMO are trained and compliant with quality standards.
• Develop and deliver training programs related to quality systems and regulatory requirements.

6. Quality Systems Analytics:

• Analyse and resolve quality system issues.
• Provide insights and identify areas for improvement within the CDQ Compliance Department and Global CDQ PMO.

Qualifications

• Bachelor’s degree in engineering, Science or related technical/scientific field

• Minimum of 3 years of experience in quality systems within the pharmaceutical industry
• Experience in a GMP environment and Document Control Systems
• Familiarity with regulatory requirements (e.g., ISO 13485, FDA, EU GMP, HPRA

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, visithttps://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