Specialist Quality Control Support - Change Control and Deviations

Role Summary

Specialist Quality Control Support - Change Control and Deviations. Lead a team responsible for QC Support, including Stability and Sample Management Teams. Support startup of laboratory electronic systems and equipment, develop a complementary team, and transition to support of Amgen North Carolina commercial product release. Reports to the Director of Quality Control and contributes to Safety, Quality, and Lean Leadership.

Responsibilities

• 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.
• Maintain strong communication with internal and external stakeholders.
• Apply strong project management, organization, and problem-solving skills.

• 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.

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 10 years of Quality Control experience OR
  • Associate‚Äôs degree and 8 years of Quality Control experience OR
  • Bachelor‚Äôs degree and 4 years of Quality Control experience OR
  • Master‚Äôs degree and 2 years of Quality Control experience OR
  • Doctorate degree
• Preferred Qualifications:
  • 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.

Skills

• Quality Control and Quality Assurance
• Change Control
• Deviations Investigation
• Root Cause Analysis
• QMS Software (TrackWise, Veeva)
• Regulatory Compliance (cGMP)
• Documentation and Technical Writing
• Cross-functional Collaboration
• Project Management

Education

• As specified in Basic Qualifications and Preferred Qualifications above

Additional Requirements

• None specified beyond qualifications; no travel or physical demands listed as essential.