Lead QC Investigations & CAPA Specialist

Initial Therapeutics, Inc.; West Greenwich (RI); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Specialist QC to support analytical investigations within the QC Technical Services team. You will lead investigations for OOS, OOT, and atypical results, performing root cause analysis and implementing CAPAs.

You will own deviations, change controls, and effectiveness verifications, collaborating with Quality, Manufacturing, and QA to ensure risk-based outcomes and inspection readiness. Excellent communication is essential in this cross-functional role.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or Life Science discipline.
• 58+ years of Quality Control or Quality Assurance experience in biotech/pharma.
• Experience leading complex laboratory investigations (OOS, OOT, atypical results).
• Strong GMP knowledge and deviation management experience.
• Experience performing root cause analysis using structured methods.

Responsibilities

• Lead QC analytical investigations for OOS, OOT, atypical results and other investigations.
• Perform root cause analysis and develop CAPAs.
• Own deviations, CAPAs, and change controls; support risk-based decisions.
• Collaborate with QC laboratories, Manufacturing, Process Development, QA, Supply Chain and other groups.
• Maintain inspection-ready documentation and support audits.

Skills

Analytical investigations

Root cause analysis

CAPA development

GMP compliance

Documentation

Cross-functional collaboration

Inspection readiness

Education

Bachelor's in Chemistry/Biochemistry/Biology/Pharmaceutical Sciences

Master's or Doctorate in Life Sciences

Tools

Laboratory instrumentation

Job description

Amgen is seeking a Specialist QC to support analytical investigations within the QC Technical Services team. You will lead investigations for OOS, OOT, and atypical results, performing root cause analysis and implementing CAPAs.

You will own deviations, change controls, and effectiveness verifications, collaborating with Quality, Manufacturing, and QA to ensure risk-based outcomes and inspection readiness. Excellent communication is essential in this cross-functional role.