Under general supervision, the scope of this position is responsible for analyzing device and subassemblies testing data and maintaining the 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 coordinating real-time stability testing for devices and their associated controls. The position is responsible as well 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. This is a 2nd shift position.
Tasks and responsibilities:
Day to day direct and train Process Analyst I and II. Ensure they are trained in all applicable processes and manufacturing procedures and that all training is properly documented.
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 Process Analyst I, II and the Cal/Testing Lab.
Coordinate the real time stability study on products and their associated controls.
Initiate, 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.
Initiate, coordinate/perform and support new software/process development and implementation.
Lead and perform In-process testing procedure/data monitoring and first-hand trouble-shooting.
Help on coordinate Analysts’ and the Cal/Testing Lab’s activities and schedules when necessary in order to meet shipment/testing timeline and requirements
Support Process, Equipment and Assembly Validations. Support transfer and validation of new products.
Draft and revise documents including MSOP’s, SOP’s, MRP’s and QTP’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. QSR’s, ISO, ISO 13485, CMDR
Follow all safety guidelines, manufacturing policies and procedures
Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc.
Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Performs other duties & projects as assigned.
- Demonstrates commitment to the development, implementation and effectiveness of Alere’s Quality Management System per ISO, FDA and other regulatory agencies.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
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:
- Six years 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.
- Ability to functionally direct junior staff.
United States of America-California-San Diego
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