Hybrid QC Analyst: Method Transfer & Compliance

Integrated Resources, Inc ( IRI ); Norton (MA); Híbrido; USD 110 000 - 140 000; Tempo integral

Resumo da oferta

Integrated Resources, Inc (IRI) is seeking a QC Analyst IV to support stability studies, data trending, investigations, and method transfers across Cambridge and Norton, MA, and client sites. Precision and regulatory compliance are essential as you collaborate with QA, CMC, Manufacturing, Regulatory, and Quality Assurance teams.

You will review QC testing, assist in regulatory submissions, and drive continuous QC process improvements while mentoring lab personnel in analytical methods and

Qualificações

• Bachelor-level science degree with GMP/QC exposure.
• Experience in technical specification development, method transfer, or analytics.
• Strong data analysis and investigative capabilities.

Responsabilidades

• Support justification of technical specs for materials and finished products.
• Transfer analytical methods from development to QC use and train staff.
• Conduct and document stability studies and trend QC data.
• Lead investigations into deviations with CAPA implementation.
• Review routine and non-routine QC testing per policies and regs.
• Prepare technical docs for regulatory submissions and audits.
• Participate in cross-functional forums (CMC, Regulatory).

Conhecimentos

Data analysis

Attention to detail

Problem-solving

Communication

Teamwork

Organizational skills

Autonomy

Formação académica

Bachelor's degree in Chemistry, Biology, or Biochemistry

Ferramentas

LabWare LIMS

Excel

Word

PowerPoint

Descrição da oferta de emprego

Integrated Resources, Inc (IRI) is seeking a QC Analyst IV to support stability studies, data trending, investigations, and method transfers across Cambridge and Norton, MA, and client sites. Precision and regulatory compliance are essential as you collaborate with QA, CMC, Manufacturing, Regulatory, and Quality Assurance teams.

You will review QC testing, assist in regulatory submissions, and drive continuous QC process improvements while mentoring lab personnel in analytical methods and