Company Details
Company: US Pharmatech NV, Inc.
Location: Las Vegas, Nevada
Job Details
Job Type: Full-time (On-site)
Pay: $55,000 - $60,000 a year based on experience
Benefits: Paid Holiday, Paid Vacation, Sick Leave, Health Insurance, Dental Insurance
Shift & Schedule: Day time (9:00 a.m. – 6p.m.) with occasional evening availability required to accommodate communication with Korea-based clients.
Company Overview:
USP NV, Inc. is a Nevada-based contract manufacturer and quality assurance center specializing in the formulation, testing, and export of dietary supplements and functional health products. Our company supports global clients, particularly Korean health brands, by providing end-to-end manufacturing, quality documentation, and regulatory support to meet both U.S. FDA and Korean MFDS (Ministry of Food and Drug Safety) standards.
We manage the entire export quality assurance process, including raw material testing, in-process inspection, finished product release, and bilingual technical documentation for cross-border compliance.
Our facility operates under cGMP certification, ISO-based quality systems, and strict traceability requirements to ensure consistent product safety and quality for international markets.
Position Summary:
US Pharmatech NV, Inc. is seeking a Bilingual Documentation & Compliance Specialist to support export-related regulatory documentation, bilingual technical communication, and quality compliance for products manufactured at our Nevada facilities and shipped to international markets.
This position focuses on the preparation, review, and coordination of quality and regulatory documentation rather than routine production work. The successful candidate will work closely with USP’s U.S.-based QA/QC and production teams while coordinating technical documentation and compliance communications with Korean clients, consultants, and regulatory stakeholders.
Because a significant portion of USP’s products are exported internationally, particularly to South Korea, this role requires strong familiarity with quality-system documentation, batch record structures, Certificates of Analysis (COA), labeling review, and bilingual (English-Korean) regulatory communication to ensure compliance with U.S. cGMP requirements (21 CFR Part 111) and Korean Ministry of Food and Drug Safety (MFDS) regulatory expectations.
Key Responsibilities:
Duties and responsibilities include, but not limited to, the following and must be performed with limited supervision.
• Prepare and maintain bilingual (English–Korean) export-related quality documentation, including Certificates of Analysis (COA), batch record summaries, product specifications, and quality release documentation for products manufactured at USP facilities.
• Review and verify QC laboratory results and production documentation to ensure that export documentation accurately reflects manufacturing records and complies with U.S. cGMP requirements and Korean MFDS documentation expectations.
• Translate and prepare bilingual technical documentation including stability summaries, quality reports, technical correspondence, and export documentation packages required by international clients.
• Review labeling, packaging text, and marketing language for export products to ensure consistency with approved product specifications, manufacturing documentation, and applicable regulatory standards.
• Coordinate bilingual technical communication between USP’s U.S.-based QA, QC, and production teams and international clients, regulatory consultants, and purchasing teams.
• Respond to quality-related documentation requests from overseas clients and assist in preparing regulatory documentation required for export shipments.
• Support QA teams in organizing and maintaining export documentation records, ensuring traceability and compliance across multiple production lines.
• Assist with the development and standardization of bilingual documentation templates and regulatory documentation procedures as USP expands production capacity and international operations.
Qualifications:
• Bachelor’s degree in English, Communications, Regulatory Affairs, or related field.
• Strong bilingual proficiency in English and Korean (written and verbal) required.
• Demonstrated ability to translate or prepare technical documentation, regulatory documents, or business communications in both English and Korean.
• Strong attention to detail and ability to maintain accurate documentation in regulated environments.
• Ability to interpret technical information such as laboratory test results, product specifications, and manufacturing documentation.
• Strong written communication and documentation skills with the ability to coordinate technical information between cross-functional teams.
• Ability to work effectively with quality assurance, production, and regulatory teams in a manufacturing environment.
Preferred Qualifications:
- Familiarity with U.S. FDA cGMP regulations (21 CFR Part 111) or quality documentation systems.
- Knowledge of Korean MFDS export documentation requirements.
- Experience supporting export documentation, regulatory submissions, or international client communications.
- Experience working with cross-border teams or coordinating documentation for international markets.