MON-2604-174
QA TECHNICIAN
NEW JERSEY

Department: Quality Assurance

Reports To: R&Q Group Director

Mission:

Strengthen, promote and capitalize on our client's competitive advantages by ensuring high-quality APIs are delivered to the market, making quality a core priority across all operations.

Responsibilities:

• Provide direct support to the R&Q Group Director at subsidiary level on all Quality Assurance activities.
• Ensure consistent quality of materials and supporting documentation delivered to customers by enforcing Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and compliance with all applicable federal, state and municipal regulations.
• Establish and maintain strong working relationships with regulatory agencies and authorities on behalf of or client, partner companies and key stakeholders.
• Act as the primary local Quality contact for third-party logistics providers and clients, and as the qualified person for internal quality compliance matters.
• Liaise with customers and regulatory authorities on quality-related topics, including hosting inspections and responding to observations.
• Review and evaluate documentation received from manufacturers and suppliers, including company information, certifications and product data.
• Supervise product reception to ensure compliance with approved specifications and authorize release for storage, or verify that subcontracted activities are performed according to the company’s quality standards.
• Prepare, update and maintain product documentation such as Certificates of Analysis, Technical Packs, Declarations, Statements and MSDS.
• Respond to questionnaires and requests for additional information from customers and authorities.
• Review processing and batch records to support product shipment release and ensure proper record keeping.
• Ensure knowledge, implementation and adherence to Quality SOPs, regulations and guidelines across operations.
• Ensure supplier regulatory listings and records are correctly maintained, including NDC, IOR and FEI.
• Participate in and lead public and private audits in collaboration with the R&Q Group Director and external stakeholders.
• Support interactions with Health Authorities to understand requirements for importation and sale of products.
• Support the logistics team in importation processes and collaborate in the company’s Supplier Qualification Program.
• Develop, update, review and implement standard operating procedures for the QA department and the subsidiary in alignment with global standards and the local Quality System.
• Perform periodic internal audits and audits of external warehouses.
• Monitor quality aspects of warehousing practices to ensure compliance with approved procedures.
• Manage product complaints in accordance with internal processes.
• Track and analyse audit data to identify systemic issues, compliance risks and process improvement opportunities, and support the definition and implementation of CAPAs and continuous improvement initiatives.
• Ensure clear, timely and structured communication with supervisors and the commercial team.
• Maintain quality documentation updated within internal computer systems.
• Enter and manage regulatory information for assigned projects in Registration Tracking databases and systems within the global RA group in Madrid.
• Support training initiatives on GDP and GMP for new employees and collaborate in the development of interdepartmental technical training plans.

Detalles / Details