US-QA Junior

Suanfarma, SA; New Jersey; On-site; USD 50,000 - 70,000; Full time

Job summary

Suanfarma, SA in New Jersey seeks a US-QA Junior to support quality assurance in the production of APIs. The role involves ensuring compliance with federal and state regulations and maintaining high-quality documentation.

The ideal candidate will liaise with regulatory authorities, oversee the reception of materials, and support audits. Strong communication skills and a commitment to continuous improvement are essential for success.

Qualifications

• Support to R&Q Group Director in quality assurance and compliance tasks.
• Develop relationships with Agencies and Authorities.
• Conduct quality inspections and respond to regulatory queries.

Responsibilities

• Ensure consistent quality of materials and supporting documentation.
• Communicate with regulatory authorities on quality matters.
• Review and evaluate documentation from manufacturers and suppliers.

Job description

### **US-QA Junior*** Country: UNITED STATES* Workplace: New Jersey* Type of contract:* Date publish: 12/05/2026* Timetable:* Vacancies: 1#### **Job description**MISSIONOur mission is to strengthen, promote and capitalize on SF`s competitive advantages to make high-quality APIs more accessible throughout the market, making quality our priority.GENERAL RESPONSABILITIESSupport to the R&Q Group Director in the following activities at subsidiary:• Assure consistent quality of the materials and support documentation is delivered to our customer by developing and enforcing good manufacturing and distribution practices and compliance with all federal, state and municipal regulations.• To establish good and permanent working relationship with Agencies and Authorities on behalf of SuanFarma, partner companies and key stakeholders.• Communicate with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations. Act as a leading link with other team members to lookout for the good end of the acquisition and supply of ingredients.• Act as primary and local QUALITY contact person with third party logistics & clients and as qualified person for internal quality compliance matters.• Liaise with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.• Review and evaluate the documentation (company, certifications, product information) received from manufacturers and suppliers.• Supervise the reception product assuring the compliance of the material with the approved specifications and release for storage or assure these activities are performed according to SF rules when they are subcontracted• Prepare and maintain updated the product documentation (COA, Tech Pack, Declarations, Statements, MSDS)• Prepare an answer to all questions and additional information requests (questionnaires, forms).• Review of processing records to support product shipment release requirements and to maintain the right records of that.• Ensure the knowledge and implementation of Quality SOPS, regulations and guidelines.COMPLIANCE & REGISTRATIONS• Ensure supplier regulatory listings & record keeping (NDC, IOR, FEIs).• Participate and lead, in collaboration with R&Q Group Director and external stakeholders involved, in public and private Audits.• Cooperate with Health Authority engagement for understanding requirements to import/sale.CONTROL OF OPERATIONS:• Support to logistics team on the process of importing goods.• Participate, support and cooperate with SF Supplier Qualification ProgramSOP AND GUIDANCES MANAGEMENT:• Develop, update/review and implementation of standard operating procedures (SOP) for QA department and SF subsidiary according Global rules and local Quality System approved by QA manager.AUDITS.• Perform periodic internal audit.• Perform periodic audit of external warehouse.• Monitoring QUALITY aspects of warehousing practices for compliance with warehouse procedure manuals.INCIDENCE MANAGEMENT• Management of product complaints according to internal procedures.• Manages audit data to track and trend meaningful metrics for use in systemic issue identification and resolution, summarizing compliance risks, process improvement opportunities and implementation of CAPAs.• Support for the development of appropriate Corrective and Preventative Actions (CAPAs) and continuous improvement activities.REPORT & COMUNICATION• Consistently communicates in clear, effective, timely, concise, and organized manner to keeps supervisor and commercial team informed.• Maintain the computer systems duly updated (with the quality documents)• To enter regulatory information for the assigned project into relevant Registration Tracking databases/systems in the global RA group in Madrid.TRAINING• Support to R&Q Group Director training on GDP/GMP to new employees and development of interdepartmental training plans for technical functions.