Senior Associate Quality Assurance PQA

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds 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 youll 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 youll 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

Lets do this. Lets 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.

Basic Qualifications:

• High school diploma/GED and 4 years of Quality manufacturing and/or other regulated environment experience OR
• Associates degree and 2 years of Quality manufacturing and/or other regulated environment experience OR
• Bachelors Degree and 6 months of Quality manufacturing and/or other regulated environment experience OR
• Masters Degree.

Preferred Qualifications:

• 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

What you can expect of us

As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture well support your journey every step of the way.

In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now and make a lasting impact with the Amgen team.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

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 disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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