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Engineering (Non IT) and Research - Quality Engineer
1 month ago
Job Title: Manufacturing Quality Engineer II
Duration: 12 Months
Location: Fremont, CA, 94538
Exact Schedule 7:30am-6:30pm M-F, OT possible, however, not likely fully onsite
Pay Rate: $45.00 Hourly
Job Description:
Position: Manufacturing Quality Engineer II, Stability
Location: Fremont, CA
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, preferably 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.
