Quality Control Chemist

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

Overview

Pharmaceutical CDMO in Boca Raton, FL is seeking an experienced Quality Control Chemist to join their team on a direct hire basis!

Responsibilities

• Review/test raw materials (RM), packaged materials (PM), in-process (IP), and finished products to ensure quality standards are met.


• Conduct method transfer and verification, including investigation of out-of-specification (OOS) and out-of-trend (OOT) results.


• Ensure laboratory compliance through audits and data integrity practices.


• Perform sampling and testing for raw and packing materials, managing distribution of work among 2-3 team members from sample collection to result generation.


• Prepare specifications for raw materials, packing materials, and finished products according to USP/US Pharmacopeia standards.


• Perform chemical testing using techniques such as FTIR, Karl Fischer titrations, and UV-Vis spectroscopy.


• Review and approve test limits and testing procedures based on pharmacopeial requirements.

Requirements

• BS/MS in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, or related discipline.


• 5-8 years of QC experience in pharmaceutical sterile injectable manufacturing.


• Experience with USP/US Pharmacopeia, including preparation of specifications and chemical testing.


• Proficiency in FTIR, Karl Fischer Titrations, and UV-Vis techniques.


• Strong knowledge of method transfer, investigations (OOS/OOT), and laboratory compliance.


• Ability to review data, perform audits, and maintain data integrity.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.