Quality Assurance Specialist- Pharma/Medical Device Long term temporary roles- 1 year

FlexStaff is seeking Quality Assurance Associates for two long term temporary roles with our client, a leading distributor of health care supplies and equipment. Must come from pharma or medical device industry. One position is focused on regulatory compliance and the other on new supplier/vendor qualification.

Job Location: onsite in Melville, New York

M-F 9:00am to 5:30pm

Temporary: April 2025-March 2026

Pay Rate: $27/hr

Quality Assurance Associate - Regulatory/Compliance Position

This position is responsible to support the compliance of the Quality Management System with Regulatory requirements and internal processes. To ensure quality of products, components and/or operations using standard procedures (e.g. ISO 13485:13485, MDSAP, 21 CFR part 211, 820, 803, 806 etc.)

• Verify UDI barcodes to ensure that the barcodes comply with FDA requirements
• Review and approve packaging/labels for all private label products to assure compliance with applicable regulatory requirements
• Represent Quality Assurance to support other departments with Quality and Regulatory issues/questions
• Participate in special projects and perform other duties as required

Other skills:

• Knowledge of FDA.
• Able to work independently.
• Effective verbal and written communication skills, excellent customer service background, data entry experienced.
• Able to follow written SOPs and formal procedural documents.
• Able to multi-task and handle multiple projects under pressure.
• Able to quickly process large volumes of administrative forms in an efficient manner with a high degree of accuracy and quality.
• Able to be flexible and change directions as necessary.
• Performs clerical functions, including but not limited to copying, filing, scanning, faxing, etc.
• Ability to follow instructions, superb attention to detail and, verbatim compliance to procedure.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Perform moderate trouble shooting with minimal supervision.
• Ability to embrace change and participate in continuous improvement activity.

Preferred Education:

• Prefer 4-year college degree in science related field with 0-1 year Quality/Regulatory experience in the pharmaceutical or medical device industry.

Quality Assurance Associate - New Vendor Qualification position

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.

• 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 the company.
• 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 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.

Specific Knowledge and Skills:

• General Knowledge of ISO 13485