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Manufacturing Quality Engineer

1 month ago

Fremont, United States TekWissen ® Full time

Position: Manufacturing Quality Engineer

Location: Fremont, CA

Duration: 12 Months

Job Type: Contract

Work Type: On Site

Shift: Monday to Friday - 07:30 AM to 06:30 PM

Pay Rate: $35 to $40/hr


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.


Position Summary:

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

Responsibilities:


  • Conducts analytical and functional testing of finished good kits and/or filled bottle reagents/calibrators according to approved SOPs as part of QC Surveillance testing.
  • Perform testing using chemistry clinical analyzers and document test results accurately using Excel spreadsheets and workbooks.
  • Perform testing according to established time points and ensure timelines are met, as required per the standard procedure.
  • Initiate out of specification investigations, as needed.
  • Perform stability testing protocols on newly launched products, as well as on market products.
  • 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.
  • Assist in performing, reviewing and/or generating validations for QC processes and laboratory equipment
  • Assist in performing stability testing of product that has implemented new raw materials and documentation
  • Provide input for brainstorming activities, support approaches for problem-solving and data analysis related to QC failures
  • Interpret and 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.
  • Participate in PPI, Lean, and 5S programs, as required.

Minimum Requirements/Qualifications:

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 1-3 yrs Quality Assurance/Quality Control experience in the medical diagnostics industry.
  • Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.
  • Understanding of cGMP and how it applies to the work environment is preferred.
  • 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 and reading comprehension skills.
  • Manual dexterity, must be able to lift/move up to 20 pounds.
  • 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.
  • The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not an exhaustive list of all of the duties and responsibilities associated with it.


TekWissen® Group is an equal opportunity employer supporting workforce diversity.