Quality Control Scientist

Indotronix Avani Group; Fremont (CA); Presencial; USD 60.000 - 80.000; Jornada completa

Descripción de la vacante

Indotronix Avani Group in Fremont, CA seeks an Engineer/Scientist I for QC laboratory testing of raw materials and intermediates. You will follow SOPs and GMPs, generate data, verify products, and operate instruments with an emphasis on accuracy and documentation.

Responsibilities include data analysis, batch record completion, trend evaluation, and support for QC activities. A BS/BA in Chemistry or Biochemistry is required with 0–2 years of experience in QA/QC or related fields.

Formación

• Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs QA/QC experience.
• Strong lab skills including pipetting and hazardous chemical handling.
• Understanding of cGMP is preferred.
• Ability to follow written and verbal directions with high accuracy.

Responsabilidades

• Test intermediate and raw materials per SOPs and GMPs.
• Perform testing using chemistry analyzers and document results in Excel.
• Document results, batch records, problems, and relevant information under cGMPs.
• Revise SOPs/worksheets as needed and initiate change orders.
• Summarize data, maintain lot histories, evaluate trends and discrepancies.
• Support department needs as assigned by Supervisor.

Conocimientos

Pipetting

Data analysis

Documentation

cGMP knowledge

Safety

Excel proficient

Independent work

Educación

BS/BA in Chemistry or Biochemistry or Bioscience

Herramientas

Excel

Descripción del empleo

• Using standard operating procedures (SOP) and good manufacturing practices (GMP), the Engineer/Scientist I will perform testing of intermediate and raw materials.
• The Engineer/Scientist I will be responsible for all aspects of laboratory testing, such as sample receipt, data generation, product verification, data analysis and summarization, instrument operation, and other QC lab supporting activities.

Responsibilities:

• Conducts analytical and functional testing of raw materials and intermediates according to approved SOPs as part of QC Raw Material testing.
• Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
• Documents test results, complete batch records, document problems and other relevant information under cGMPs.
• Perform simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
• Summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
• Performs other responsibilities to support the needs of the department as assigned by Supervisor.

Minimum Requirements/Qualifications:

• Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
• Strong laboratory skills including pipetting, safety, and hazardous chemical handling.
• Understanding of cGMP and how it applies to the work environment is preferred.
• High level of reading comprehension skills.
• Ability to follow written and verbal directions with a high level of accuracy.
• Must be able to write clear, understandable documentation.
• High level of verbal communication skills.
• Intermediate word processing and spreadsheet software skills.
• Ability to manage multiple tasks simultaneously.
• Ability to work independently.
• Ability to perform simple data analysis and to summarize results.
• Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts