Formulations Specialist I/II (1st Shift)

This is a first shift position, 5am-1pm. The Formulations Specialist I/II formulates reagents in a controlled manufacturing environment. This position also executes validation studies, executes test protocols, occasionally investigates Non-Conformances, evaluates processes & procedures, reviews specifications, and inspects & tests equipment. May conduct training on reagent formulations, quality related tools, methods, and procedures. Interfaces with R&D, Manufacturing, Quality, and Supply Chain within the company and when appropriate with customers and suppliers on quality related issues. Your key responsibilities Follows cGMP and ISO standards or guidelines as they apply to manufacturing Supports Manager with formulation of solutions, from line clearance through dispensing/capping of vials, following standard operating procedures and guidelines; solutions include aqueous solutions containing salts, organics, acids, bases and/or modified DNA and organic solutions Reviews manufacturing batch records as directed for accuracy and adherence to good documentation practices prior to in-process items release Conducts and analyzes test results for compliance to specifications and reports abnormalities. Responsible for on-time completion of scheduled work orders Ensures the effective use of materials, equipment, and Formulations team members in producing quality products Supports departmental projects. Partners with QC, PTS, QA and/or R&D on OOS/NCR/CAPA investigations as needed Support Management with validation and stability studies, executes protocols, analyzes data, generates reports, investigates non-conformances for MRB Prepares operating procedures and work instructions to govern lab processes and for the introduction of new items into Formulations team production May lead special projects as needed and perform additional duties as required Who you are A.A.S. or B.S. degree, preferred, in basic sciences, life sciences, or engineering and/or five (5) years of experience in a formulation manufacturing environment Minimum two years of relevant work experience in a medical device company Understanding of the requirements for working in a GMP, GLP, ISO certified or FDA work place Technical knowledge of molecular biology is highly desirable Demonstrated ability to support fast track investigations Training and experience in basic statistical analysis tools and Design of Experiments (DOE) methodology preferred Ability to execute change orders under the guidance of higher level employees or area management Knowledge of basic statistics relevant to interpretation and analysis of scientific data; An understanding of the characterization of assay performance and knowledge of statistical-based DOE methodologies is desirable Knowledge of safety precautions required for working with biohazards and blood borne pathogens Knowledge of Quality System Regulations Relocation is not available for this position Who we are A member of the Roche Group, GenMark’s ePlex true sample-to-answer system symbolizes the evolution of eSensor technology combined with digital microfluidics. ePlex offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the only true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California. GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law. Job Level: Individual contributor