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At Amgen, our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases.
Our award-winning culture is collaborative, innovative, and science-based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team.
Job Description
The QA Specialist - Aseptic Officer provides aseptic subject matter expertise and oversight to operational activities associated with the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under minimal supervision, the role provides compliance and aseptic oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Responsibilities
Acts as the Quality organization's main point of contact and subject matter expert for all topics related to aseptic processing. Partners with colleagues in Manufacturing, Supply Chain, Facilities, and Engineering to maintain a strong culture of Quality and Safety. Provides Quality Oversight of the manufacturing facility, including manufacturing operations, testing, inspection, and utilities. Participates in and provides quality oversight for quality records, including Deviations, Change Controls, and CAPAs. Performs impact assessments as part of change controls impacting production or QA processes. Provides quality expertise and guidance to operational staff and within cross-functional Amgen teams. Reviews and approves controlled documents, including Standard Operating Procedures, Protocols, and Reports. Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. Participates in Amgen internal/external audits and inspections. Contributes to and drives continuous improvement projects in cross-functional collaboration. Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver departmental and manufacturing plant goals. Basic Qualifications
Doctorate degree Or Master's degree and 2 years of quality experience Or Bachelor's degree and 4 years of quality experience Or Associate's degree and 8 years of quality experience Or High school diploma / GED and 10 years of quality experience Preferred Qualifications
Bachelor's Degree in Science 5 plus years of aseptic processing experience in QA or Manufacturing Experience with leading or supporting an aseptic program for Drug Product operations Excellent interpersonal, verbal, and written communication skills Experience leading and directly coaching staff to drive improved performance and focus on operational excellence Strong level of analysis skills to evaluate and interpret information Experience applying problem-solving tools for root cause analysis Strong leadership capabilities and proven experience applying GMP requirements in an operational setting 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.
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The QA Specialist - Aseptic Officer provides aseptic subject matter expertise and oversight to operational activities associated with the aseptic Drug Product manufacturing areas at Amgen, Thousand Oaks. Under minimal supervision, the role provides compliance and aseptic oversight to Manufacturing and Facilities & Engineering staff in the implementation of their processes, procedures, and use of quality systems. Responsibilities
Acts as the Quality organization's main point of contact and subject matter expert for all topics related to aseptic processing. Partners with colleagues in Manufacturing, Supply Chain, Facilities, and Engineering to maintain a strong culture of Quality and Safety. Provides Quality Oversight of the manufacturing facility, including manufacturing operations, testing, inspection, and utilities. Participates in and provides quality oversight for quality records, including Deviations, Change Controls, and CAPAs. Performs impact assessments as part of change controls impacting production or QA processes. Provides quality expertise and guidance to operational staff and within cross-functional Amgen teams. Reviews and approves controlled documents, including Standard Operating Procedures, Protocols, and Reports. Ensures that operations align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls. Participates in Amgen internal/external audits and inspections. Contributes to and drives continuous improvement projects in cross-functional collaboration. Represents the Quality function and provides quality oversight during the implementation of projects required to improve and deliver departmental and manufacturing plant goals. Basic Qualifications
Doctorate degree Or Master's degree and 2 years of quality experience Or Bachelor's degree and 4 years of quality experience Or Associate's degree and 8 years of quality experience Or High school diploma / GED and 10 years of quality experience Preferred Qualifications
Bachelor's Degree in Science 5 plus years of aseptic processing experience in QA or Manufacturing Experience with leading or supporting an aseptic program for Drug Product operations Excellent interpersonal, verbal, and written communication skills Experience leading and directly coaching staff to drive improved performance and focus on operational excellence Strong level of analysis skills to evaluate and interpret information Experience applying problem-solving tools for root cause analysis Strong leadership capabilities and proven experience applying GMP requirements in an operational setting 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.
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