Pharma Operations & Deviation Specialist (2nd Shift)

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 Savings Plan with 2x

Education Assistance Program

Paid Holidays

Job summary

Simtra US LLC is seeking an Operations Support Specialist to partner with manufacturing shifts within an Operations Focus Factory. You will support deviation events, capture critical details, initiate investigations, and drive compliant return-to-service after incidents.

You will author deviations, manage CAPAs and CI actions, and ensure documentation integrity across shifts, collaborating with QA, Engineering, and MSAT as needed.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field or equivalent experience.
• Ability to cover 2nd/3rd shift and weekend AM/PM as needed.
• Strong written communication to translate events into clear narratives.
• Experience collaborating with Manufacturing, QA, SMEs, and site support functions.

Responsibilities

• On-shift deviation event response with Manufacturing and QA teams.
• Author manufacturing deviation investigations with root cause analysis and CAPAs.
• Maintain inspection-ready records and ensure GMP/GDP compliance.

Skills

Written communication

Attention to detail

Team collaboration

GMP / GDP knowledge

Education

Bachelor's degree in Life Sciences or Engineering

Tools

GMP documentation

Job description

Simtra US LLC is seeking an Operations Support Specialist to partner with manufacturing shifts within an Operations Focus Factory. You will support deviation events, capture critical details, initiate investigations, and drive compliant return-to-service after incidents.

You will author deviations, manage CAPAs and CI actions, and ensure documentation integrity across shifts, collaborating with QA, Engineering, and MSAT as needed.