Quality Assurance Specialist

Amgen•Holly Springs, NC

44d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. 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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. 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. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Quality Assurance Specialist What you will do Let’s do this. Let’s change the world. In this vital role you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen’s Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsible for providing Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA) Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports. Oversee and provide guidance during on-the-floor analytical testing. Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality Assurance professional we seek is a Specialist with these qualifications.

Requirements

High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Associate’s degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Bachelor’s degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Master’s degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR
Doctorate degree

Nice To Haves

Educational background in Life Science or Engineering.
Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations.
Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition
Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian)
Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations.
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations.
Experience participating in, managing, and responding to health authority inspections, partner and corporate audits.
Strong organizational skills, including ability to follow assignments through to completion.
Excellent written and verbal communication skills.

Responsibilities

Serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA).
Work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
Foster a strong partnership and learning environment between Manufacturing and Quality staff.
Provide coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems.
Provide Quality oversight to ensure that Operations’ products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls.
Perform review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA)
Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports.
Oversee and provide guidance during on-the-floor analytical testing.
Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
Ensure that changes that could potentially impact product quality are assessed according to procedures.
Ensure that deviations from established procedures are investigated and documented per procedures.
Alert senior management of quality, compliance, supply and safety risks.
Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation.
Identification and implementation of continuous improvement opportunities within our processes and systems
Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections.