Specialist-Manufacturing Investigations

Specialist Quality Control Support - Change Control and Deviations page is loaded## Specialist Quality Control Support - Change Control and Deviationsremote type:
On Site locations:
US - North Carolina - Holly Springs time type:
Full time posted on:
Posted Todayjob requisition :
R-226829##
** Career Category
** Quality## ##
** Job Description**## 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  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.
** Specialist Quality Control Support - Change Control and Deviations**##
** What you will do
** Let’s do this. Let’s change the world. In this vital role, you will lead a team responsible for QC Support. This group is responsible for Stability and Sample Management Teams. Responsibilities include the startup and validation of the laboratory electronic systems and equipment for the labs as well developing a complementary team of individuals. This role will support site start up and then transition to support of Amgen North Carolina commercial product release.

The Specialist QC Support will report directly to the Director of Quality Control and as a member of this leadership team, you will contribute to encouraging and further developing the culture of Safety, Quality, and Lean Leadership.
** Change Control
*** Develop and manage the change control process at ANC in line with FDA, EU GMP, and other regulations.
* Partner with system owners and cross-functional teams to assess impact and risk.
* Ensure documentation (justifications, impact assessments, validation needs, implementation plans) is accurate and complete.
* Present at Change Control Review Board (CRB) meetings and initiate changes in QMS (Track Wise or Veeva).
* Track and report change status to leadership, ensuring timely review and closure.
* Maintain strong communication with internal and external stakeholders.
* Apply strong project management, organization, and problem-solving skills.
** Deviations
* ** Lead deviation investigations from initiation to closure in QMS (Veeva), meeting established timelines.
* Perform root cause analysis using industry tools (e.g., 5 Whys, 5M).
* Collaborate with QC teams (Chemistry, Bioassay, Microbiology, EM) to gather data and support investigations.
* Write clear, scientifically sound investigation reports with corrective actions.
* Assess product quality and patient safety impact.
* Develop, implement, and track CAPAs to prevent recurrence.
* Review historical deviations for trends and repeat events.
* Manage follow-ups, including effectiveness checks for CAPAs.
* Support audits and regulatory inspections by presenting investigation findings.##
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is a dynamic team player with…