Specialist Quality Control Support - Change Control and Deviations

Amgen • Holly Springs, NC

86d

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.

Requirements

• High school diploma / GED and 10 years of Quality Control experience OR Associate's degree and 8 years of Quality Control experience OR Bachelor's degree and 4 years of Quality Control experience OR Master's degree and 2 years of Quality Control experience OR Doctorate degree.

Nice To Haves

• Degree in Pharmaceutical Sciences, Biotechnology, Chemistry, or Microbiology.
• Experience in Quality Control and Quality Assurance roles in pharmaceuticals or biopharma, with focus on deviations and change controls.
• Strong knowledge of cGMP regulations, quality systems, and regulatory compliance.
• Hands-on experience with change controls for equipment, computerized systems, or facility modifications.
• Skilled in technical writing, root cause analysis (e.g., 5 Whys, Fishbone), and investigation reporting.
• Familiarity with QMS software (TrackWise, Veeva).
• Excellent communication skills with cross-functional teams and regulatory authorities.
• Ability to manage multiple priorities independently in a fast-paced environment.

Responsibilities

• Lead a team responsible for QC Support, including Stability and Sample Management Teams.
• Startup and validation of laboratory electronic systems and equipment.
• Develop a complementary team of individuals.
• Support site startup and transition to support of Amgen North Carolina commercial product release.
• 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 (TrackWise or Veeva).
• Track and report change status to leadership, ensuring timely review and closure.
• 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.

Benefits

• Competitive and comprehensive Total Rewards Plans aligned with local industry standards.

What This Job Offers

• Industry: Chemical Manufacturing