Job Description Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, Ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements. Competencies/Skills: Understand, support and demonstrate values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution. Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating Qualifications Expertise in Technical Writing, must have written reports for investigations, method transfers/validations, • Root Cause Analysis experience and CAPA identification and implementation • Fully bilingual English/Spanish • Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts) • Presentation skills • Oriented to solve problems and troubleshoot, technical proficiency • Simple statistical assessments Doctorate degree in Sciences or Master’s degree in Sciences & 3 years of directly related experience or Bachelor’s degree in Sciences & 5 years of directly related experience • BS in Chemistry or Biochemistry preferred • Knowledge in TrackWise, CDOCS, Maximo • Knowledge in PowerPoint, Excel, Word, One Note
