Career Category

Job Description

Join Amgen's Mission to Serve Patients

At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.

Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.

If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.

Manager Quality Assurance I

What you will do

The Incoming Material Manager Quality Assurance is responsible to lead IQA team which is part of the Lot Disposition group of the Quality Assurance function.

The IQA team provides expertise in performing inspection, sampling and testing of incoming materials to meet Amgen specifications and ensure a constant supply of raw materials for ASM.  The team provides these crucial services to ensure only raw materials meeting Amgen specification and sourced from approved vendor are used to manufacture products for our patients.

Main Responsibilities:

• Responsible for leading and directing IQA staff

• Responsible for providing Quality oversight to ensure material inspection, sampling and rapid ID testing performed in accordance to written SOPs, Methods, Good Manufacturing Practices (cGMP) and other applicable regulations

• Comply with safety guidelines and procedures

• Complete required assigned training prior to execution of required tasks

• Ensure Raw Materials inspection, sampling and rapid ID testing are documented in accordance with Good Documentation Practice Principle

• Ensure controlled documents for the area of responsibility that require periodic review have an active owner assigned

• Ensure document periodic review activities are completed on time for documents owned by assigned areas of responsibility

• Review records to ensure raw materials are tested and inspected according to specification and SOPs

• Perform business operations related to inspection/sampling/testing (i.e. updating dashboards, relevant metrics, housekeeping, inventory management, audit support)

• Support site/network Continual Improvement initiatives

• Ensures facilities, equipment, materials and procedures comply with cGMP practices and other applicable regulations

• Alert management of quality, compliance, supply and safety risks in a timely manner

• Performs review, approval and tracking of cGMP processes, procedures, documents and records, including but not limited to Nonconformances, CAPAs and Change Control records and Protocols.  May also support execution of these tasks

• Ensures that changes that could potentially impact product quality are assessed according to procedures

• Ensures that deviations from established procedures are investigated and documented per procedures

• Ensure no overdue Deviation and CAPAs

• Represents IQA function during audits and inspections as needed and ensure successful audit and Regulatory Inspections

• Conduct trouble shooting and problem solving related to systems and operations

• Conduct onboarding training to new hires

• Maintenance of IQA related equipment

• Performs additional duties as specified by management

• Provide coaching, guidance, talent development and performance review for IQA team

What we expect of you

• Doctorate Degree

• Master’s degree and 2 years of experience in pharmaceutical company or GMP environment OR

• Bachelor’s degree and 4 years of experience in pharmaceutical company or GMP environment OR

• Diploma and 8 years of experience in pharmaceutical company or GMP environment

• At least 5 years of experience in Pharmaceutical Industry

• Experience and basic troubleshooting skills with laboratory and process equipment

• Experience with LIMS, SAP, TrackWise

• Ability to lead the team effectively and develop high performing team

• Ability to understand, apply and evaluate basic chemistry and single use materials

• Ability to adhere to regulatory requirements, written procedures and safety guidelines

• Ability to evaluate documentation/data according to company and regulatory guidelines

• Ability to interact with inspectors (internal and external)

• Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge

• Ability to organize work, handle multiple priorities and meet deadlines

• Detail oriented as well as flexible and adaptable to changing priorities and requirements

• Ability to perform computer operations, such as ability to navigate in MS Office and complete Computer Based Training (CBT)

• Ability to handle first tier problem solving that may involve cross functional interactions

• Proficient written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

What you can expect of us

As we work to develop medicines for patients, we also invest in our people. Through competitive benefits, development opportunities, and a collaborative culture, we'll support your growth both professionally and personally.

Apply now and help transform the lives of patients while transforming your career.

careers.amgen.com

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 as we 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.