GMP Operations Support – Deviation & CAPA Specialist

Simtra US LLC; Bloomington (IN); On-site; USD 39,000 - 52,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Retirement Savings Plan with 1:

Paid Holidays

Paid Time Off

Education Assistance

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking an Operations Support Specialist to partner with Manufacturing and Quality on deviations and CAPA actions. The role writes and closes deviations, drives continuous improvement, and ensures compliance during manufacturing operations.

This position requires strong written communication, cross-functional collaboration, and the ability to support multiple investigations while maintaining quality standards.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field or equivalent experience.
• Strong written communication and ability to work with cross-functional teams.
• Ability to manage multiple investigations and CAPA actions with quality mindset.

Responsibilities

• On-shift deviation event response with Manufacturing and QA to capture events and preserve investigation data.
• Author complete deviation investigations with root cause analysis and corrective actions.
• Drive deviations and CAPA closures while coordinating with multiple SME groups.
• Maintain inspection-ready records and participate in shift handoffs and reviews.

Skills

Written communication

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences, Engineering, or related field

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking an Operations Support Specialist to partner with Manufacturing and Quality on deviations and CAPA actions. The role writes and closes deviations, drives continuous improvement, and ensures compliance during manufacturing operations.

This position requires strong written communication, cross-functional collaboration, and the ability to support multiple investigations while maintaining quality standards.