Quality Control Chemist

Duties And Responsibilities

• Counsels equipment maintenance program in QC including calibration and preventative maintenance.
• Identifies non-compliance within regulations and standards.
• Supports BPE to analyze and solve problems related to product failures and customer complaints.
• 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.
• 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.

Qualifications

• 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 flow cytometry technology.
• Familiarity with use of BD Flow Cytometers.
• Familiarity with product, instrument, and/or process validations.
• Proficient at operating instrumentation, including Thermocycler, sequencer, AGFC, and flow cytometers.
• Familiar with PCR and general molecular biology techniques.