Senior QC Chemist – Sterile, Method Transfer & OOS/OOT

Joulé; Boca Raton (FL); On-site; USD 65,000 - 90,000; Full time

Job summary

System One in Boca Raton, FL seeks an experienced Quality Control Chemist to join a pharmaceutical CDMO on a direct hire basis. The role includes reviewing RM/PM/IP/finished products, performing testing, and upholding USP quality standards.

You will conduct method transfer and investigations (OOS/OOT), ensure laboratory compliance, audits, and data integrity, and perform FTIR, Karl Fischer titrations, and UV-Vis analyses to support release and GMP compliance.

Qualifications

• Experience in QC within pharmaceutical sterile injectable manufacturing.
• Familiarity with USP/US Pharmacopeia requirements and specifications.
• Ability to review data, perform audits and maintain data integrity.

Responsibilities

• Review raw materials, packaging materials, in-process, and finished products for quality.
• Conduct method transfer and verification, including investigations of OOS and OOT results.
• Ensure laboratory compliance through audits and data integrity practices.
• Perform sampling and testing, manage workload among team members from sample collection to results.

Skills

Quality control

OOS/OOT investigations

Data integrity

Audits

Education

BS or MS in Chemistry/Pharmaceutical Sciences

Tools

FTIR

Karl Fischer titration

UV-Vis spectroscopy

Job description

System One in Boca Raton, FL seeks an experienced Quality Control Chemist to join a pharmaceutical CDMO on a direct hire basis. The role includes reviewing RM/PM/IP/finished products, performing testing, and upholding USP quality standards.

You will conduct method transfer and investigations (OOS/OOT), ensure laboratory compliance, audits, and data integrity, and perform FTIR, Karl Fischer titrations, and UV-Vis analyses to support release and GMP compliance.