Quality Assurance Associate at Ledgent Technology in Melville, New York

Job Description:

Contract Duration - 1 Year
Location - Melville, NY 11747
Max Pay - $27


JOB DESCRIPTION


This position is responsible to assist in the new vendor qualification process, and assist in the review of changes made to internal drug class codes within the internal JDE system. Participate in special projects and performs other duties as required.


Key Responsibilities:


Typically responsible for the following duties:

• Manage Regulatory Item Creation Inbox


• Item Creation Attribute Verification Maintenance.


• PIX Regulatory Error Resolutions.


• Create, update/revise standard operating procedures, work instructions and/or forms.


• Maintain Global inspections tracker (i360).


• Reviews and approves new vendor qualification documents for onboarding into Henry Schein.


• Provide support to Corporate Brand Development and marketing Group, answering questions pertaining to regulatory issues.


• Provide support to Corporate Brand Development Group and other Business Units researching issues pertaining to regulatory matters. Secure and maintain proper company licensure and product registration as needed to support HSI Operations and Business Units.


• Participate in special projects and performs other duties as required.

General Skills and Competencies:

• Professional skills with an understanding of industry practices and company policies and procedures.


• Developing proficiency with tools, systems, and procedures.


• Good planning/ organizational skills and techniques.


• Developing problem solving skills.


• Good writing and communication skills.


• Excellent time management skills and the ability to prioritize work


• Excellent conflict resolution skills.


• Good decision making skills.


• Excellent interpersonal skills.

Travel/Physical Demands:

• Office environment. No special physical demands required.

Specific Knowledge and Skills:

• Understanding of regulations applicable to HS operations


• General Knowledge of ISO 13485

TECHNICAL SKILLS


Must Have

• Ability to multi-task


• Ability to work in a team environment


• Able to follow written SOPs and formal procedural documents.


• Accountability


• Detailed Oriented


• Good planning/ organizational skills and techniques.


• Microsoft Office

Nice To Have

• Knowledge of ISO, FDA and able to work independently. Effective verbal and written communication skills, excellent customer service background, data entry experienced. Prefer 4-year college degree in science related field with 0-1 year Quality/Regulatory experience in the pharmaceutical or medical device industry.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions. Apply Now