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SUMMARY
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.
EDUCATION
-Doctorate OR -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR -High school/GED + 10 years of directly related experience.
COMPETENCIES/SKILLS
-Understand, support and demonstrate the AMGEN 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.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
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.
EDUCATION
-Doctorate OR -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR -High school/GED + 10 years of directly related experience.
COMPETENCIES/SKILLS
-Understand, support and demonstrate the AMGEN 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.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*