Senior QC Lab Specialist & Validation Lead

Biopharma Careers; Colorado; On-site; USD 75,000 - 122,000; Full time

Job summary

Boehringer Ingelheim is seeking a Specialist to provide technical and quality oversight for QC analytical testing in a multi-product facility. You will act as SME during audits, lead non-routine transfers and validations, and drive process improvements across the QC group.

The role emphasizes training, cross-functional collaboration, and adherence to cGMP/cGDP standards, with focus on maintaining compliance and data integrity across methods and projects.

Qualifications

• BS/BA in a science or engineering field with 4 years in analytical testing in GMP setting or
• MS/MA with 2 years in analytical testing in GMP setting or equivalent.
• PhD with 2 years in analytical testing in GMP setting or equivalent.

Responsibilities

• Provide technical and quality oversight for non-routine QC method transfers, validations, qualifications and assessments.
• Lead group on equipment qualifications for new or novel technologies.
• Act as QC SME during audits and audits for cross-functional teams.
• Drive improvements in lab processes, compliance, and training.
• Manage training and cross-training, document deviations and investigations.

Skills

QC oversight

Audit readiness

Technical leadership

SOP knowledge

Data interpretation

Education

BS/BA in science or eng

MS/MA in science or eng

PhD in science or eng

Tools

SOP drafting tools

Quality systems (CAPA/Deviations)

Job description

Boehringer Ingelheim is seeking a Specialist to provide technical and quality oversight for QC analytical testing in a multi-product facility. You will act as SME during audits, lead non-routine transfers and validations, and drive process improvements across the QC group.

The role emphasizes training, cross-functional collaboration, and adherence to cGMP/cGDP standards, with focus on maintaining compliance and data integrity across methods and projects.