BD (Becton, Dickinson and Company) QC Chemist II in San Jose, California
Job Description 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 product meets the standards or pre-determined requirements. The QC Chemist is responsible for conducting routine and non-routine analysis of data results. Work closely with the product development team to perform Gage R&R studies to define QC specs and perform robustness studies to provide handling information for QC protocols. Create a partnership with R&D, BPE and Quality and integrate manufacturing validation activities.
Proficient at operating instrumentation, including Thermocycler, sequencer, AGFC, and flow cytometers. Familiar with PCR and general molecular biology techniques.
DUTIES AND RESPONSIBILITIES
Conducts tests on raw materials, in process and finished goods as assigned. Coordinate’s 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.
Effective written and communication skills
Knowledge of general laboratory safety, GMP's and associated regulatory requirements
Experience with SAP
Familiarity with basic flowcytometry technology
Familiarity with use of BD Flow Cytometers
Familiarity with product, instrument, and/or process validations
Primary Work Location
USA CA - San Jose (Reagents)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.