Quality Control Chemist

Job Title Quality Control Chemist Job Summary Quality 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 the 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. Location San Jose, CA Duration 12+ Months Contract Employment Type Contract on W2 (Need US Citizens or GC Holders Only) Duties and Responsibilities Conduct tests on raw materials, in-process and finished goods as assigned. Coordinate equipment maintenance program in QC including calibration and preventative maintenance. Contact vendor for service when needed. Identify non-compliance within regulations and standards. Support BPE to analyze and solve problems related to product failures and customer complaints. Provide supports in problem characterization, data acquisition and analysis. Prepare and submit SOP, WI, BOM, routings and standard costing for new products into SAP. Write Engineering Change Orders (ECO). Submit prepared documents for approval. Participate in QC Test Method validation activities. Support BPE to analyze and solve problems in designing, writing, executing of protocols, reports, data analysis and other quality documents. Keep abreast of basic requirements for compliance in own area of work and comply with those requirements and raise concerns/issues to management. Promote a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participate in environmental health and safety programs. Address corrective actions whenever a hazard is identified. Notify 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 handling 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. #J-18808-Ljbffr