Quality Control Chemist

Position: Quality Control Chemist

Location: San Jose, CA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Job Category: Quality

Level Of Experience: Seniority Level

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

No H1B’s

Description:

Title : Quality Control Chemist
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 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
1. Conducts tests on raw materials, in process and finished goods as assigned.
2. Coordinates equipment maintenance program in QC including calibration and preventative maintenance. Contacts vendor for service when needed.
3. Identifies non-compliance within regulations and standards
4. Supports BPE to analyze and solve problems related to product failures and customer complains. Provide supports in problem characterization, data acquisition and analysis.
5. Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
6. Writes Engineering Change Orders (ECO). Submits prepared documents for approval.
7. Participates in QC Test Method validation activities,
8. Supports BPE to analyze and solve problems in the designing, writing, and executing of protocols, reports, data analysis and other quality documents.
9. 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.
10. 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
1.Proficient at operating instrumentation, including Thermocycler, sequencer, AGFC, and flow cytometers.
2.Familiar with PCR and general molecular biology techniques.