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Company

Original Job Post

ZymoChem · 3 days ago

Quality Control Associate

San Leandro, CA

Full-time

Onsite

Entry Level

$68K/yr - $89K/yr

1+ years exp

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BiotechnologyChemical

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Responsibilities

Perform testing and data collection for commercially scalable R&D pilot processes for the production of our first-of-its-kind bioproduct

Record all testing data & results in both written and digital form in the laboratory database for record keeping

Collating test data and drafting quality reports and identifying possible areas for improvement in quality control processes as needed

Ensure and optimize the test process, new method development and validation to enhance the quality testing & productivity for both incoming raw materials and final product

Inspecting goods or products according to quality and safety standards and ensuring compliance with company standards as well as Federal and State law

Report results, review data and advise supervisor of materials not meeting specifications including assisting in troubleshooting quality issues

Perform routine calibrations and troubleshooting on instruments and document the calibration

Creation of Certificates of Analysis for product release along with support team for sample shipment to customer(s), third-party testing labs or vendors

Maintain GLP (Good Laboratory Practices) contributing to laboratory maintenance and operational systems including equipment troubleshooting and repair

Maintain inventory control of retains, supplies and chemicals as necessary to support QC/R&D systems

Communicate clearly and concisely, both verbally and in written reports. Contribute to the revision of laboratory procedures as necessary for the quality department's operations

Draft, review, and execute written protocols for QC analytical procedures, qualification, validation, and technology transfer

Support in set-up, plan, research, perform and complete lab projects as required

Work cross functionally with other departments to support business operational needs

Perform additional duties as assigned.

Qualification

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Quality controlData collectionLaboratory proceduresAnalytical proceduresEquipment operationCalibrationCGMP regulationsFDA guidanceEU guidanceData managementRecordkeepingExtended hoursSafety protocolsProblem-solvingAttention to detailCommunicationTime managementMultitaskingAdaptabilityImprovisationMS OfficeGoogle SuiteZoomSlack

Required

AA degree or Bachelor's degree in Materials Sciences, Chemistry, Biotechnology, Engineering, or life sciences with equivalent work experience required

Minimum of 1+ year of industrial/startup experience working directly with quality control

Previous experience performing test and data collection for commercially scalable R&D products is highly preferred.

Knowledge of basic laboratory and analytical procedures

Ability to operate equipment including basic maintenance and calibration

Knowledge of cGMP regulations and FDA/ EU guidance related to manufacturing

Strong aptitude for hands-on work with equipment along with a rigorous attention to details with procedures, instrumentation, data management, and recordkeeping

Strong verbal, written, and interpersonal communication skills in a fast-paced environment

Capability and willingness to work extended days, off-peak hours, and weekends

Excellent time management skills, effective with multitasking, and an adept ability to improvise work plans while maintaining efficiency

Ability to follow safety protocols and procedures

Must be able to move up to 25 pounds and move around the lab facility between multiple locations for extended periods