QC Chemist

Job Title: QC Chemist (cGMP / HPLC / Solid Dose)
Location: Cranbury, NJ (Onsite)
Type: Contract-to-Hire
Schedule: 40 hrs/week
Shift: M-F 8am-5pm
Pay: $36-$40 per hour depending upon experience

Overview

This is a hands-on, laboratory-based Quality Control role supporting batch release and stability programs within a cGMP pharmaceutical manufacturing environment. We are seeking candidates with strong operational QC experience supporting solid oral dosage manufacturing (tablets / capsules) in a fast-paced, production-driven environment, coupled with hands-on experience with HPLC / UPLC analysis.

Responsibilities

• Perform batch release and stability testing for pharmaceutical products
• Conduct assay, dissolution, impurity, and related substances testing
• Operate, calibrate, and troubleshoot HPLC / UPLC systems
• Maintain GMP documentation and ensure audit readiness (ALCOA)
• Investigate OOS / OOT results and support CAPA activities
• Manage stability programs, sample pulls, and trending analysis
• Collaborate with QA and Manufacturing to meet production timelines

Requirements

• 6-8+ years of pharmaceutical QC experience (cGMP REQUIRED)
• Strong background in solid oral dosage (tablets, capsules)
• Recent hands-on experience with HPLC / UPLC (REQUIRED)
• Experience with assay, dissolution, impurities, and stability testing
• Working knowledge of FDA, GMP, ICH guidelines
• Experience with Empower, LIMS, or similar systems
• Strong documentation, data integrity (ALCOA+), and troubleshooting skills
• Ability to work independently and in a fast-paced manufacturing setting

Key Skills

QC Chemist, Quality Control Analyst, cGMP, GMP, Pharmaceutical, Solid Dose, Solid Oral Dosage, Tablets, Capsules, HPLC, UPLC, Dissolution, Assay, Impurities, Stability Testing, Batch Release, OOS, OOT, CAPA, FDA, ICH, Empower, LIMS, Analytical Chemistry, Drug Product, Manufacturing, Validation

Benefits

Medical, Dental, Vision, 401(k), Life Insurance, and additional voluntary benefits

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.

#M3

Ref: #558-Scientific