Quality Control Chemist

System One, Inc.; Boca Raton (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

System One, Inc. is seeking a Quality Control Chemist in Boca Raton, FL for a direct hire, onsite role. The ideal candidate has 5–8 years of QC experience in sterile injectable pharma and proficiency with USP standards and analytical techniques.

You will review materials and processes, perform method transfers, ensure data integrity, and supervise a small team through sampling, testing, and compliance activities.

Qualifications

• BS or MS in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, or related field.
• 5–8 years of QC experience in pharmaceutical sterile injectable manufacturing.
• Experience with USP/US Pharmacopeia and test method development/verification.

Responsibilities

• Review/test RM, PM, IP, and finished products for quality compliance.
• Conduct method transfer and verification incl. OOS and OOT investigations.
• Ensure laboratory compliance through audits and data integrity practices.
• Perform sampling and testing for raw/packing materials; manage 2–3 team members.
• Prepare specifications for RM, PM, and finished products per USP standards.
• Perform FTIR, Karl Fischer titrations, and UV-Vis testing.
• Review/test limits and procedures based on pharmacopeial requirements.

Skills

Quality control

Method transfer

Data integrity

Audits

Education

BS in Chemistry

MS in Chemistry

Tools

FTIR

Karl Fischer titration

UV-Vis spectroscopy

Job description

Job Title: Quality Control Chemist
Location: Boca Raton, FL
Type: Direct Hire
Compensation: $70,000-$90,000/year
Work Model: Onsite, Monday - Friday Day

Overview

Developing 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.