Senior Associate Quality Assurance - PQA

Amgen•Holly Springs, NC

17h

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. Senior Associate Quality Assurance - PQA What you will do Let’s do this. Let’s change the world. The Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. The Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. Support Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines. Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support. Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation 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. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. 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 professional we seek is a collaborative partner with these qualifications.

Requirements

High school diploma/GED and 4 years of Quality, manufacturing and/or other regulated environment experience OR Associate's degree and 2 years of Quality, manufacturing and/or other regulated environment experience, OR Bachelor's Degree and 6 months of Quality, manufacturing and/or other regulated environment experience OR Master's Degree.

Nice To Haves

Strong cGMP and GDP behaviors
Experience in biotechnology or pharmaceutical plant start up
Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment
Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
Demonstrated experience with deviations records
Experience supporting GMP testing laboratories.
Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines
Strong communication skills, both written and oral
Demonstrated ability to work as a team player and independently

Responsibilities

Support Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems.
May include support on commissioning and qualification and validation activities in addition to new document support.
Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation 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.
Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations.
Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements.
Oversee and provide guidance during on-the-floor analytical testing.
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.