Quality Control Chemist III

Position Summary

The QC Chemist conducts research on, analyzes and experiments with all pharmaceutical dosage forms and raw materials for purposes of product development, quantitative analysis to determine how much of one substance is mixed with another, process applications and qualitative analysis to develop and improve products. Analyzes organic and inorganic materials to determine their chemical and physical makeup.

Essential Functions

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

• Evaluates the chemical and physical properties of various organic and inorganic substances such as active and in-active raw materials in order to verify the compliance with the established specifications.
• Provokes changes in the composition of the materials using a variety of measures including dissolution testing, spectroscopic and wet chemistry techniques.
• Relies on verbal and written instructions and pre-established guidelines to prepare and maintain reports based on scientific deductions. Validates analytical test methods, critically evaluates and audits data, writes technical analytical reports and procedures.
• Test samples to insure compliance with FDA and cGMP requirements according to approved written procedures and specifications. Perform, assay, assisting in the validation of assays, and writing test methods.
• Instrumentation includes high level of complexity and difficulty eg GC, HPLC.
• Responsible for biological and / or chemical evaluation of final product, intermediate products, raw materials, and production facilities.
• Requires labeling packaging or movement of hazardous materials within the facility and must comply with local, state and federal regulations regarding disposal of these types of toxics.
• Performs a variety of tasks. May lead and direct others for specific smaller projects. A certain degree of creativity and latitude is expected.
• Checking/Reviewing of analytical data if required by following test methods & related SOP’s.

Experience and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and education required:

• Education & Experience
  • Bachelor’s degree in Chemistry or related science field with seven (7) to ten (10) years lab experience in a pharmaceutical chemical or related industrial experience; preferably solid dosage forms manufacturing.

or

• Master’s degree or higher with five (5) to seven (7) years of progressive lab experience in a pharmaceutical chemical or related industry; preferably generic pharmaceuticals.

• Industry Knowledge
  • Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required.

• Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus

Knowledge, Skills and Abilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required :

• Computer Skills
  • Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry required.
• Mathematical Skills
  • Math skills commensurate with scientific background is required.

• Requires a strong knowledge of algebra, calculus and statistics and how they are applied.

• Communication Skills
  • Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations.
  • Ability to write reports, and required documentations.

• Reasoning Ability
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
  • Must possess initiative and trouble shooting ability.

Working Environment

The physical demands and working environment of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.

• Physical
  • Requires use of PPE (personal protective equipment) when in designated areas of the facility.

• The work requires some physical exertion such as long periods of standing, walking, reaching or similar activities.
• No special physical demands are required to perform the work.

• Environmental
  • Work involves every day risks or discomforts requiring special safety precautions.
  • Employee generates hazardous waste during the performance of daily job responsibilities.
  • Must exercise extreme safety and precaution at all times in all situations.

~ Compensation based on experience ~

~ Jubilant Cadista offers an excellent benefit package which includes but is not limited to Health, Vision, Dental, 401K ~

~ Relocation assistance available if relocation is required ~

Apply directly at www.Jubl.com or email updated resume to Tanya.John@jubl.com

It is the policy of Jubilant Cadista Pharmaceuticals, Inc. (herein “Cadista”) to provide equal employment opportunity to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sexual orientation, gender identity and/or expression, marital status, status as a disabled veteran and/or veteran of the Vietnam Era or any other characteristic protected by federal, state or local law. In addition, Cadista will provide reasonable accommodations for otherwise qualified disabled individuals.