Japanese Localization Quality Assurance Tester Jobs in Delaware

Reporting to the QC Analytical Lead, the QC Raw Material Scientist will serve as a technical expert in analytical chemistry testing and laboratory operations supporting the release of raw materials, excipients, active pharmaceutical ingredients (APIs), process materials, and packaging components used in pharmaceutical manufacturing at WuXi STA’s Middletown, DE site.  This role is responsible for the execution, troubleshooting, transfer, and validation of analytical methods used for incoming material testing while ensuring compliance with cGMP requirements, compendial standards, corporate quality systems, and global regulatory expectations. The QC Raw Material Scientist will support material disposition, supplier qualification, investigations, and regulatory inspections to ensure an uninterrupted supply of qualified materials for manufacturing operations.

QC Raw Material Testing and Support

• Perform and review QC analytical testing of raw materials, APIs, excipients, and packaging components according to approved specifications, pharmacopeial methods, and SOPs.
• Execute compendial and non-compendial analytical methods including HPLC, UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer, wet chemistry, identification testing, and other applicable techniques.
• Perform raw material identity testing in accordance with regulatory requirements and internal procedures.
• Support sampling plans and testing strategies for incoming materials.
• Conduct laboratory investigations associated with out-of-specification (OOS), out-of-trend (OOT), atypical results, and laboratory deviations related to raw materials.
• Troubleshoot analytical instrumentation and methods and implement scientifically sound corrective actions.
• Support supplier qualification and material assessments through analytical evaluation and trending of test results.
• Author, review, and revise raw material specifications, test methods, protocols, SOPs, and technical reports.
• Mentor and train QC Analysts on raw material testing techniques, GMP requirements, and laboratory best practices.
• Collaborate with Warehouse, Manufacturing, Procurement, Quality Assurance, and Supply Chain teams to ensure timely disposition of incoming materials.
• Support establishment of raw material testing capabilities during site startup and commercial operations.

Regulatory Compliance and Documentation

• Ensure all laboratory activities are conducted in compliance with cGMP regulations, data integrity principles (ALCOA+), safety requirements, and company quality systems.
• Maintain complete, accurate, and inspection-ready laboratory records.
• Support qualification, validation, verification, and transfer of analytical methods used for raw material testing.
• Support qualification and lifecycle management of laboratory instruments and computerized systems.
• Review analytical data and approve test results for material release decisions.
• Participate in audits and regulatory inspections and provide technical responses related to raw material testing programs.
• Escalate quality events, OOS results, supplier-related concerns, and compliance issues to QC management in a timely manner.
• Support continuous improvement initiatives to enhance laboratory efficiency, compliance, and turnaround times.

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline with 5+ years of QC analytical laboratory experience in a GMP-regulated pharmaceutical or biotechnology environment; OR
• Master’s degree with 3+ years or PhD with 1+ years of relevant QC analytical laboratory experience.
• Strong experience with raw material release testing, compendial testing, and material disposition processes
• Demonstrated expertise in chromatographic, spectroscopic, and wet chemistry techniques including HPLC/UPLC, GC, FTIR, UV-Vis, TOC, Karl Fischer, and pharmacopeial analytical methods.
• Experience leading laboratory investigations, troubleshoot instrumentation, and author technical reports.
• Strong understanding of USP, EP, JP, ICH, FDA, and cGMP requirements applicable to raw material testing.
• Strong technical writing skills with experience authoring specifications, SOPs, protocols, and investigation reports.

Preferred Qualifications

• Experience supporting raw material programs in pharmaceutical manufacturing, or CDMO environments.
• Experience with supplier qualification, vendor change assessments, and material risk evaluations.
• Experience performing FTIR identity testing and compendial verification activities.
• Familiarity with LIMS, Empower, SAP, or similar laboratory and ERP systems.
• Experience with method transfers, validation, and regulatory inspections.
• Strong communication and cross-functional collaboration skills supporting Quality Assurance, Supply Chain, Manufacturing, and external suppliers.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.  Employees holding this position will be required to perform any other job-related duties as requested by Management.