Operations Deviations Specialist – Nights & Weekends

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical & Dental

401(k) Plan

Paid Holidays

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks an Operations Support Specialist to partner with manufacturing shifts, capture deviation details, and drive timely investigations and CAPA actions. The role requires strong GMP knowledge, rigorous documentation, and collaboration with QA, Engineering, and MSAT to ensure compliant returns to production.

The embedded position focuses on deviation event response, root cause analysis, and continuous improvement to strengthen aseptic practices and

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field; equivalent experience considered.
• Strong written communication skills for clear investigation narratives.
• Ability to work with Manufacturing, QA, SMEs in a fast-paced environment.

Responsibilities

• Author manufacturing deviation investigations with clear event chronology and evidence.
• Drive deviations to timely closure with cross-functional input.
• Own CAPA actions and CI initiatives related to processes and documentation.
• Support shift handoffs, deviation reviews, and Focus Factory discussions.

Skills

GMP knowledge

Root cause analysis

Technical writing

Team collaboration

Education

Bachelors in Life Sciences

Tools

GxP systems

Deviation tracking tools

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks an Operations Support Specialist to partner with manufacturing shifts, capture deviation details, and drive timely investigations and CAPA actions. The role requires strong GMP knowledge, rigorous documentation, and collaboration with QA, Engineering, and MSAT to ensure compliant returns to production.

The embedded position focuses on deviation event response, root cause analysis, and continuous improvement to strengthen aseptic practices and