QC Engineer / Scientist I

Overview:   

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. 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.

Job Title:         QC Engineer / Scientist I
Duration:         12 Months    
Location:         Fremont, CA - 94538
Job type:          Contract 
Work type:      Onsite
Shift:                 Monday to Friday from 08:00 AM to 05:00 PM
Overtime:        Minimal

Position Overview:

• Using standard operating procedures (SOP) and good manufacturing practices (GMP), the QC Engineer/Scientist I will perform testing of raw materials as part of the Incoming Material process before they can be used to build filled components and finished goods kits.
• The QC Engineer/Scientist I will be responsible for all aspects of laboratory testing, such as sample receipt, data generation, data analysis and summarization, instrument operation, and other QC lab supporting activities.

Key Responsibilities:

• Conducts analytical and functional testing of raw materials according to approved SOPs
• Perform testing using typical laboratory instrumentation, including 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 the Supervisor.
• Participate in PPI, Lean, and 5S programs, as required.

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.
• Must be Comfortable working with biological materials (testing can be done on blood and urine).
• Demonstrated ability and/or additional experience may be considered instead of a BS/BA degree.
• 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.
• 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 summarize results.
• Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.