Product Release Specialist III Job in San Diego, California US
Product Release Specialist III
Product Release Specialist III Department: Quality Assurance Direct Hire position in San Diego, CA Summary Incumbent is responsible for reviewing Final Product batch records. Maintains metrics of Product Release performance on a monthly basis and performs process improvements with the Product Release Area. Leads the resolution of all minor compliance issues. In addition, performs process improvements projects within the Product Release Area Essential Duties and Responsibilities including the following. · Other duties may be assigned. Coordinate/Perform the Final Product Batch Record review and release process. · Interacts with the Manufacturing Department to resolve minor issues related to the review process and deviations. · Coordinates/Perform Batch Record review of Intermediate Batch Records, and Autoclave Runs as needed. · Interacts with the Manufacturing Department to resolve issues related to the review process and deviations. · Ensures/Maintains the Product Release Database up to date. Coordinates time to comply the Product Release schedule. · May perform improvements to the database to improve efficiency or to include new products/projects. · Collaborate with different members of the QA Department working in special projects and on additional assignments as directed by the Supervisor. Qualifications: · To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. · The requirements listed below are representative of the knowledge, skill, and/or ability required. · Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience: · Associate s degree from a two-year College and 8 to 12 years of related experience in batch record review and/or training; · or equivalent combination of education and experience. · Bachelor s degree in a scientific discipline preferred. Knowledge and Skills/Abilities: · Required strong computer skills, Microsoft Office Applications Access, Excel, Word · Must be detailed oriented, be able to follow detailed instructions, possess excellent time management skills, be well organized, a self starter and display a professional demeanor with a high focus of quality, compliance and responsibilities. · Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date: ability to closely monitor and communicate progress on daily tasks and responsibilities to Management · Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities · Verbal communication skills English Knowledge of Good Manufacturing Practices/ Quality System Regulations and ISO Standards required. · Must be able to work a consistent schedule to satisfy to responsibilities of the job Language Skills · Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. · Ability to write reports, business correspondence, and procedure manuals. · Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. · Mathematical Skills: · Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. · Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. · Must be able to perform mathematic calculations, from simple to complex cell counts, viability and determine viable cell count . Reasoning Ability · Ability to define problems, collect data, establish facts, and draw valid conclusions. · Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Kelly Scientific Resources Kelly Scientific Resources is the largest scientific staffing supplier in the world* Recruiting Scientific and Clinical Research professionals since 1995 involving in cutting edge technology that impact our lives Operating on four continents, 20 countries with ongoing expansion 80 locations in North America, Europe, and the Pacific Rim Over 8500 scientists and clinical research professionals on assignment globally on an average workday Largest Supplier to the National Institute of Health