BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Process Analyst I, 3rd Shift to work for a leading San Diego biotechnology company.
Process Analyst I, 3rd Shift
Under general supervision, the scope of this position is responsible for analyzing device and subassemblies testing data and maintaining their database. The position is responsible for developing methods/reports to analyze data to predict product quality and summarize product performance periodically. The position is also responsible for assisting in product quality improvements, supporting resolution of field-reported performance issues, transferring and validation of new products, and implementation of product improvements, which increase quality, lower cost, and increase manufacturing capacity.
Tasks and responsibilities:
Analyze product/subassemblies testing data. Release product/subassemblies based on the analysis result.
Maintain product/subassemblies testing database.
Analyze In-process data to predict product quality.
Summarize Calibration/Final Pouch Release data to monitor product performance.
Provide manufacturing procedure-related and product performance-related technical guidelines to the Cal/Testing Lab.
Coordinate/perform and support improvement/trouble-shooting projects to increase the quality of the product, decrease product cost, improve product dating, and increase production capacity.
Coordinate/perform and support new software/process development and implementation.
Perform In-process testing procedure/data monitoring and first-hand trouble-shooting.
Support Process, Equipment and Assembly Validations. Support transfer and validation of new products.
Draft and revise documents including MSOPâ€™s, SOPâ€™s, MRPâ€™s and QTPâ€™s.
Establish and maintain lines of communication to ensure the timely and accurate flow of information. Incumbent will interact with representatives from QA/QC, Quantitative Assembly, Reagent Manufacturing and R&D, etc.
Knowledge of each process for which the incumbent is directly or indirectly responsible. Familiar with all current quantitative manufacturing procedures and policies.
Collaborate with Manager to establish objectives, milestones, and timelines for completion.
Perform tasks either independently or within a team with general ongoing direction.
Maintain records, databases, and notebooks in a neat, thorough, and accurate manner.
Operate complex laboratory and testing equipment and conduct tasks in a safe manner adhering to established guidelines and applicable regulations.
Knowledgeable of federal and other regulations, e.g. QSRâ€™s, ISO, ISO 13485, CMDR
Follow all safety guidelines, manufacturing policies and procedures. Operate under QSRs ISO, OSHA compliance.
Work involving blood or other potentially infectious materials may be required.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâ€™s policies and practices.
Preferred educational background:
BA or BS in Chemistry, Biological Sciences, or related field with laboratory coursework directly applicable to duties. MS in the above fields preferred.
Preferred experiential background:
A minimum of two years (BA/BS) or one year (MS) lab experience in a diagnostic field.
Demonstrated interpersonal and technical skills to meet all duties.
Able to work with a variety of people on multiple tasks and/or ability to operate as an individual contributor.
Must be detail-orientated, self-motivated and available for flexible scheduling.