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Posted about 1 month ago

  • Sector: Scientific
  • Contact: Michael Menzer
  • Contact Email:
  • Contact Phone: (732) 353-4231
  • Start Date: 2021-07-19
  • Job Ref: 21-11783
Job Summary:
The Chemist - QC is responsible for performing testing of Stability Product, following SOPs and written procedures QCMs for clear, concurrent documentation performed during testing to calculate and report results on applicable specifications/C O A. Follow cGMP regulations and understands the US FDA monographs, CFR Guidelines. Chemist must maintain quality of organization and meet compliance under USP regulations while working under fast-paced environment to meet priority deadlines.
Reporting Relationships                                                                                  
  • This position has no direct reports.
Essential Functions:
  • In a team environment, perform duties which includes but not limited to assisting work, disciplines, coaching, training to Quality control Stability employees.
  • Maintains laboratory documentation with details of test procedures, raw data and final results in accordance with regulatory guidelines.  
  • Performs Calibrations, Standardization's, and routine maintenance of instrumentation as needed.
  • Performs QC Stability testing for drug products. Performs other QC activities such as method transfer within Quality.
  • Perform Physical testing, Perform sampling (raw materials, Cleaning validation, and micro) according to approved procedures.
  • Working knowledge in operation of Laboratory equipment used for chromatographic testing (HPLC/GC) , atomic absorption spectrophotometer and other laboratory analytical equipment (UV spectrophotometer, pH and analytical balances, Moisture analyzer, Hardness tester, Friabilator, Disintegration Tester etc).  
  • Manages routine testing support for QC samples (Dissolution/HPLC/GC/Physical testing), Conducts laboratory disposition of materials (waste/expired chemicals) under cGMP guidelines.  
  • Ensuring that laboratory documentation complies with regulatory guidelines. Responds to out-of-specification test results in accordance with regulatory guidelines and quickly isolates material issues from testing issues.
  • Maintains operations-focused high throughput, quick responsive materials release testing which meet the needs of internal/external customers and business goals.
  • Responsible for three Quality Control laboratories including Wet Lab, Dissolution Lab, and HPLC lab.
  • All other job-related duties.
Specialized Skills and Knowledge:                                                                                  
  • Minimum BS in Chemistry or science related field with 0-5 years of experience in science regulated discipline. Wet chemistry, dissolution, HPLC/GC Chromatography functional knowledge is preferred.
  • Working knowledge of a variety of laboratory analytical techniques and instruments including many of the following: pH meters, Analytical balances, Moisture analyzer, Hardness tester and Friabilator.
  • Ability to operate different types of Chromatographic software related to HPLC/GC. Familiar with Chromatographic software such as Class VP, waters Empower, and EZ Chrom,etc.
  • Understands and uses good quantitative techniques in performing analytical tests and has the math skills to ensure correct calculation of the final result.         Has the ability to understand and follow written methodologies in accordance with cGMP standards.  Understands and applies USP general chapters.  
  • Computer skills for operation of laboratory equipment and for data processing/storage.  
  • Working knowledge and interpretations of cGMP.