OSD Deviation Investigations Lead

Integrated Resources, Inc ( IRI ); Town of Florida (NY); On-site; USD 75,000 - 95,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) seeks a qualified Investigator I to lead cGMP investigations for Oral Solid Dose (OSD) manufacturing. The role demands a strong understanding of production processes and exceptional analytical skills.

The successful candidate will have a Master’s or Ph.D. in a scientific field, with at least 2 years of experience in the pharmaceutical industry, focusing on Deviation Investigations and CAPAs. Effective communication and problem-solving skills are crucial for this position.

Qualifications

• Minimum 2 years of experience in the pharmaceutical industry, specifically in Deviation Investigations.
• Experience in CAPAs and FDA Audit exposure.
• Experience supporting investigations within pharmaceutical manufacturing preferred.

Responsibilities

• Lead and perform cGMP investigations supporting Oral Solid Dose (OSD) manufacturing.
• Author and coordinate high-quality investigations ensuring timely root cause identification.
• Apply scientific judgment to evaluate manufacturing data and processes.

Skills

Technical writing and documentation skills

Analytical and problem-solving capability

OSD manufacturing knowledge

Knowledge of cGMP

Effective cross-functional communication

Education

Master’s or Ph.D. degree in a scientific or engineering discipline

Tools

Electronic quality systems

Deviation/CAPA systems

MES

LIMS

Job description

Integrated Resources, Inc ( IRI ) seeks a qualified Investigator I to lead cGMP investigations for Oral Solid Dose (OSD) manufacturing. The role demands a strong understanding of production processes and exceptional analytical skills.

The successful candidate will have a Master’s or Ph.D. in a scientific field, with at least 2 years of experience in the pharmaceutical industry, focusing on Deviation Investigations and CAPAs. Effective communication and problem-solving skills are crucial for this position.