Manufacturing Deviation & CAPA Lead (Ops Support)

Simtra US LLC; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Plan

Paid Holidays

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with manufacturing shifts within an Operations Focus Factory. The role writes and closes deviations, drives CAPA actions, and supports deviation investigations with cross-functional teams to ensure quality and compliance.

You will author structured investigations, use 5 Whys and Fishbone analysis, and work with QA, Engineering, and MSAT to ensure timely closure and continuous improvement.

Qualifications

• Bachelor's degree in Life Sciences, Engineering or related field
• Strong written communication skills and ability to translate events into investigations
• Experience in sterile, aseptic, or highly regulated manufacturing environments

Responsibilities

• Authorize and write manufacturing deviations with clear event chronology and root cause
• Drive deviation closures and CAPA actions on schedule
• Coordinate with Manufacturing, QA, Engineering and other SMEs across shifts
• Maintain inspection-ready records and follow GMP, data integrity, and change control procedures

Skills

Deviation investigations

CAPA ownership

Root cause analysis

Good Manufacturing Practice (GMP)

Written communication

Education

Bachelor's degree in Life Sciences or Engineering

Job description

Simtra BioPharma Solutions is seeking an Operations Support Specialist to partner with manufacturing shifts within an Operations Focus Factory. The role writes and closes deviations, drives CAPA actions, and supports deviation investigations with cross-functional teams to ensure quality and compliance.

You will author structured investigations, use 5 Whys and Fishbone analysis, and work with QA, Engineering, and MSAT to ensure timely closure and continuous improvement.