Sr QC/Validation Chemist

Job Title : Sr. QC / Validation Chemist (cGMP, HPLC, Solid Dose)
Location: Cranbury, NJ (Onsite)
Type : Contract-to-Hire
Pay Rate: $43.00 – $46.00/hour (depending upon experience)
Schedule : 40 hours/week, M-F 8am -5 pm (flexibility for OT as needed)

Overview
Seeking a senior-level QC / Validation Chemist to support analytical testing, method validation, and manufacturing operations in a cGMP pharmaceutical environment. This is a hands-on role ideal for candidates with strong solid oral dose (tablet/capsule) experience and a background in high-throughput QC labs.

Key Responsibilities

• Perform analytical testing supporting QC, stability, and batch release
• Conduct dissolution, assay, impurities, related substances, and content uniformity testing
• Execute and support analytical method validation, verification, and method transfer (R&D to QC)
• Investigate OOS / OOT results, deviations, and support CAPA activities
• Prepare and review validation protocols, reports, SOPs, and GMP documentation
• Operate and troubleshoot HPLC, UPLC, GC, dissolution, UV-Vis, FTIR, Karl Fischer
• Utilize Empower and LIMS for data integrity and reporting
• Ensure compliance with cGMP, FDA, ICH, ALCOA+ standards
• Support manufacturing timelines through data review and troubleshooting

Qualifications

• 10+ years of pharmaceutical QC and/or Analytical R&D experience (cGMP REQUIRED)
• Strong hands-on HPLC / UPLC experience (REQUIRED)
• Expertise in solid oral dosage forms (tablets, capsules)
• Proven experience with dissolution, assay, impurities, and stability testing
• Strong background in method validation, verification, and transfer
• Experience with OOS/OOT investigations, deviations, and CAPA
• Working knowledge of FDA, ICH, GMP, ALCOA+ data integrity standards
• Experience with Empower and/or LIMS
• Strong documentation, troubleshooting, and independent working ability

Ideal Profile

• Background in commercial pharmaceutical manufacturing required
• Comfortable in fast-paced, production-driven QC environments
• Strong analytical troubleshooting and data review experience
• Reliable, detail-oriented, and able to lead by example in the lab

Key Skills: QC Chemist, Senior QC Analyst, Validation Chemist, cGMP, GMP, Pharmaceutical Manufacturing, Solid Dose, Solid Oral Dosage, Tablets, Capsules, HPLC, UPLC, Dissolution, Assay, Impurities, Related Substances, Stability Testing, Batch Release, Method Validation, Method Transfer, OOS, OOT, CAPA, FDA, ICH Guidelines, Data Integrity, ALCOA+, Empower, LIMS, Analytical Chemistry, Drug Product, High-Throughput QC, Manufacturing Support

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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Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, 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.