Quality Control Chemist
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Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B's

Description

Title : Quality Control ChemistQuality control chemists prepare and test samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the standards or requirements of the project. Work closely with product development team to perform Gage R&R studies to define QC specs and perform robustness study to provide handling information for QC protocols. Create a partnership with R&D, BPE and Quality integrate manufacturing validation activities.

Position: Quality Control ChemistLocation: San Jose, CADuration: 12+ Months ContractTotal Hours/week: 40.001st ShiftClient: Medical Device CompanyJob Category: QualityLevel Of Experience: Seniority LevelEmployment Type: Contract on W2 (Need US Citizens Or GC Holders Only)No H1B'sDescriptionTitle : Quality Control ChemistQuality control chemists prepare and test samples from all phases of a manufacturing or other handling process, with the goal of determining if the substance meets the standards or requirements of the project. Work closely with product development team to perform Gage R&R studies to define QC specs and perform robustness study to provide handling information for QC protocols. Create a partnership with R&D, BPE and Quality integrate manufacturing validation activities.Duties And Responsibilities

• Conducts tests on raw materials, in process and finished goods as assigned.
• Coordinates equipment maintenance program in QC including calibration and preventative maintenance. Contacts vendor for service when needed.
• Identifies non-compliance within regulations and standards
• Supports BPE to analyze and solve problems related to product failures and customer complains. Provide supports in problem characterization, data acquisition and analysis.
• Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
• Writes Engineering Change Orders (ECO). Submits prepared documents for approval.
• Participates in QC Test Method validation activities,
• Supports BPE to analyze and solve problems in the designing, writing, and executing of protocols, reports, data analysis and other quality documents.
• Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements and raises concerns/issues to the management.
• Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices

Education And Experience

• Requires a minimum of a Bachelor's degree in biological sciences or related field and a minimum of 3 years of hands on laboratory experience in a reagent process development or reagent manufacturing environment or Master's degree in related field.
• A minimum of 1 year experience in a FDA or ISO/GMP regulated production environment
• Experience/Familiar with PCR technique, DNA quantification (UV absorbance and fluorescence based detection), DNA fragment analysis (Bioanalyzer, Tapestation, Caliper or equivalent) Illumina sequencing (Sequencing by Synthesis) or equivalent platform.
• Experience with cell handing or flow cytometry will be a plus.

Preferred - PCR Techniques

• Effective written and communication skills
• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• Experience with SAP
• Familiarity with basic flow cytometry technology
• Familiarity with use of BD Flow Cytometers
• Familiarity with product, instrument, and/or process validations

Desired Skills

• Proficient at operating instrumentation, including Thermocycler, sequencer, AGFC, and flow cytometers.
• Familiar with PCR and general molecular biology techniques.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesStaffing and Recruiting

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