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/hour depending upon experience
Overview
Seeking an experienced QC Chemist / Quality Control Analyst to support batch release, stability testing, and analytical testing in a cGMP pharmaceutical manufacturing environment. Ideal candidates will have strong experience with solid oral dosage forms (tablets/capsules) and hands-on HPLC/UPLC analysis.
Key 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
Keyskills
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 (via System One)
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.
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