Job Description SUMMARY The Specialist Quality Control role, functions as lead investigator and as the technical specialist for testing & development in areas of Biochemistry Molecular Biology and Microbiology. Focus on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Responsible for performing root cause analysis investigations and translating into actionable actions to prevent recurrences Provide investigational reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise Approve lab investigations Responsible for providing technical guidance Provide reports, data analysis and ensure flow of communication between technical groups including following up 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. Represent Quality Control in triage meetings to assess events identified by staff 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 BASIC EDUCATION AND EXPERIENCE Doctorate degree in Life Sciences OR Master's degree in Life Sciences & 3 years of experience in Quality Control and/or GMP Laboratories. OR Bachelor's degree in Life Science & 5 years of experience in Quality Control and/or GMP Laboratories. PREFERRED QUALIFICATIONS Understand, support and demonstrate the AMGEN values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills in English. Strong computer operation skills including word 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. Experience with Operational Excellence tools 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 Excellent communications skills in Spanish and English Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Ciudad: juncos
