Analytical Chemist - Research & Development
Edison, New Jersey
Experience: 3
Category: Scientific & Clinical
Brand: Joule
Compensation Range: 25.00 - 30.00 Per Hour
Job ID: 296956
Date Posted: 04/26/2023
Shortcut: http://jobs.systemoneservices.com/v3bgXJ
Title: Analytical Chemist - Research & Development
Duration: Temp to hire
Start date: ASAP
Location: Edison NJ
Responsible for:
- Conduct analytical method development, method validation/verification, method transfer, stability studies, analytical testing in support of drug product development.
- Write method validation/verification protocols, reports, release specifications, test methods, test reports, CoAs, SOPs and prepare CMC required documentation in support of ANDA submission, per necessary.
- Work as Analytical Project Leaders on cross function teams such as Formulation group, Manufacturing Group, Quality Assurance, Quality Control, and interface with internal/external clients to meet required project timeline.
- Maintain laboratory equipment log, calibration log, inventory supplies, safety records, training records, notebooks, and all related documentation in compliance with the company SOPs, EHS standards, compendia and cGMP/GLP requirements.
- Attend/conduct in house training sessions as per to functions.
- Perform data review of cGMP/GLP analytical testing on raw materials, intermediates, finished products, stability testing, validation reports, qualification data per necessary.
- BS in Analytical Chemistry, Pharmaceutics, or related field.
- BS with 5+ years of experience in Analytical method development and validation in the pharmaceutical industry.
- Familiar with modern analytical instrumentation including HPLC, GC, KarlFisher, UV/VIS, FTIR, Dissolution testing.
- Knowledge of cGMP/GLP and compendia guidelines.
- Proficient in Microsoft Office toolkits and be able to write test methods, protocols and reports.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, 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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