QC Chemist

6/4/21

Boston, MA 02108

1257

FullTimeRegular

QC Chemist

The Chemist/Senior Chemist is responsible for the technology transfer of analytical methods to the QC Lab (i.e., Qualification or Validation)

Senior Chemists will train and qualify junior chemists on these procedures.

  • Prepares protocols and reports for the technology transfer of analytical methods to the QC Lab.
  • Train and qualify QC Lab Analysts and Technicians on analytical methods used in the QC Lab.
  • Performs OOS investigations as required.
  • Independently prepares scientific reports and documents and presents findings. Independently collect, analyze and interpret data, recognize aberrant results.
  • Understands the chemical and mathematical rationale behind test methods and their calculations.
  • Perform trouble shooting of equipment and test methods.
  • Review and approve analytical data as needed.
  • Attends project meetings and prepares project updates .
  • Maintain a safe, clean, well-organized, and efficient laboratory work environment.
  • Perform other testing or projects as required by the QC Lab Director.
  • Represent the QC Lab Director in her absence.

QUALIFICATIONS:

  • Minimum BSc. in Science, Chemistry or Analytical Chemistry
  • Knowledge of CGMP, ICH and FDA guidelines.
  • Knowledge of manufacturing environments and laboratory techniques and procedures in the execution of projects on target with quantity, quality, timeline, and safety expectations.
  • Understand procedures and policies, Good Documentation Practices, and Good Analytical Laboratory Practices.
  • Excellent written and verbal communication skills with high attention to detail.
  • Sound knowledge of Instrumental analysis and wet chemistry as well as operation of HPLC, GC, FTIR, UV-Vis spectrophotometer, KF, polarimeter, viscosity meter and standard QC instrument. Agilent and Open Lab knowledge desired.
  • Minimum 5-7 years related experience in a CGMP QC lab of pharmaceutical industry for Senior position
  • Excellent understanding of mathematical related calculations.
  • Demonstrates ability to exercise good judgment and make decisions quickly

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