Master QC Associate — Analytical Methods SME

Boehringer Ingelheim GmbH; Northern (KY); Híbrido; USD 56.000 - 83.000; Jornada completa

Descripción de la vacante

Boehringer Ingelheim GmbH seeks a Senior QC specialist to lead and execute analytical testing across multiple methods in a highly regulated biopharma environment. You will perform technical reviews, trend analysis, and investigations of atypical results while ensuring strict cGMP adherence and thorough documentation.

Ideal candidates will train others, participate in audits, and contribute to method transfers/validations; a strong background in analytical chemistry and teamwork is essential.

Formación

• High School Diploma with six years' experience in cGMP.
• Associate Degree with four years' experience in cGMP.
• Bachelor's Degree in a science or engineering field with two or more years in cGMP.
• Master's Degree with one year in cGMP.
• Experience with analytical methodologies in biopharmaceutical manufacturing.
• Strong written and verbal communication skills.
• Ability to work independently with minimal supervision.
• Proven experience with technical review, analysis and interpretation of scientific data.
• Ability to train others as an SME.

Responsabilidades

• Execute non-routine analytical testing methods with SME expertise.
• Perform technical review, data trending, and investigations of atypical results.
• Document work per cGMP and GDP standards; draft SOPs and forms.
• Represent the department during audits and coordinate method transfers/validations.
• Train others and lead compliance trainings as an SME.
• Maintain lab areas following 5S principles and safety standards.

Conocimientos

Technical review

Data interpretation

Independent work

Team collaboration

Analytical chemistry

Educación

High School Diploma

Associate Degree

Bachelor's Degree

Master's Degree

Descripción del empleo

Boehringer Ingelheim GmbH seeks a Senior QC specialist to lead and execute analytical testing across multiple methods in a highly regulated biopharma environment. You will perform technical reviews, trend analysis, and investigations of atypical results while ensuring strict cGMP adherence and thorough documentation.

Ideal candidates will train others, participate in audits, and contribute to method transfers/validations; a strong background in analytical chemistry and teamwork is essential.