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Quality Assurance Associate

Spectraforce Technologies
United States, North Carolina, Raleigh
500 West Peace Street (Show on map)
Sep 03, 2025
Job Title: Quality Assurance Associate Location: Remote (100% remote or hybrid if able to access a Canada office) Duration: 12 Months (Initial Assignment) Support Region: Canada and U.S. Job Summary: The Quality Assurance (QA) Associate is responsible for operating and maintaining a local Quality Management System (QMS) in compliance with both local regulations and global standards. This role supports quality activities across Canadian and U.S. businesses, ensuring the company's products meet applicable quality and regulatory requirements. The QA Associate acts as a key liaison for quality operations and may serve as a deputy for regulatory and pharmacovigilance functions as needed. Main Responsibilities and Accountabilities: 1. Maintains the Quality Management System in compliance with local regulations and standards, including but not limited to: Deviation Management. Corrective Action & Preventive Action (CAPA) Management. Product Complaints Management. Change Control Management. Documentation Management. Training Management. Recall Management. Self-Inspection Management. Quality Risk Management. And recommendation for improvements to the quality system supporting business in the countries. 2. Implements the Quality Management Systems in daily operations: Responsible for remaining compliant with all Quality products licensed, marketed, or supplied within the Territory of responsibility. Responsible for staying compliant with local as well as international regulations (e.g. GDP) and maintaining inspection readiness. Oversees the legal documentation required to maintain compliance with the assigned Territory, Market, or Region. Maintains up-to-date Quality Agreements. Implements and maintains local Quality procedural documentation (in accordance with Global policies and procedures and the local document management system). Monitors performance indicators related to quality compliance. Resolves quality-related issues. Archives and maintains all quality documents in line with procedures and legal requirements. 3. Self-inspections & Quality Audits Management Supports and participates in corporate organization audits and assists in audit preparation activities. 4. Product Recalls & Field actions Management Acts as Affiliate Recall Coordinator and promptly performs any recall operations for all distributed products according to procedures and local regulations. Coordinates with marketing authorization holders and national competent authorities in the event of recalls. Supports as required in the event. 5. Product Returns Management Ensures product returns are managed efficiently. Responsible for processing products based on the final disposition of returned products. 6. Verification of Suppliers and Customer Status Ensures that only qualified GMP/GDP-relevant suppliers, vendors and customers are used. 7. Management of Unlicensed Products Ensures that any additional requirements imposed on certain products by national / regional law are adhered to e.g., specials, unlicensed imports 8. Final administrative release of all product batches Ensures all batch documentation and transportation documents are available and compliant with local / region requirements to make a final decision on whether or not to release in SAP. 9. Contact with Local Regulatory Agency Acts as deputy to the LQO/RQO contact point to report or liaise with distributors if any quality related supply chain issues with batches delivered to the Affiliate / region as not meeting the requested quality criteria. 10. Affiliate Deputization Operational Support. (Include responsibilities that are applicable to specific affiliates and/or distributor markets) Minimum Requirements: At least 1 year of experience in the pharmaceutical industry, of which 1 year of experience in Quality Management Systems. Understands and has experience in pharmaceutical quality assurance systems. Knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and local regulations and guidelines as applicable to the level of activities carried out at the affiliate or region. Fluent in local or regional languages and good knowledge of oral and written English. Sound and balanced judgment; able to assess and handle risks; self-confident, proactive, and decisive. Works and communicates effectively and collaboratively across affiliate functions and other global functions and external partners or third parties.