Aseptic Ops & Compliance Specialist

Doist; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Day One Medical & Dental

Flexible Spending Accounts

Life and AD&D Insurance

401(k) with company match

Paid Holidays

Paid Time Off

Parental Leave

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Science and Compliance Specialist to provide technical guidance on aseptic practices and equipment. You will draft SOPs, support production through troubleshooting, and lead end-to-end deviation investigations while maintaining cGMP records. The role requires strong CAPA execution and audits support.

Schedule: Friday-Sunday 7:00am-7:30pm. Benefits include Day One Medical & Dental, FSA options, life insurance, 401(k) matching, and more.

Qualifications

• BS degree in science/technical field or equivalent aseptic pharmaceutical manufacturing experience.
• 2+ years technical writing experience in pharmaceutical industry.
• Knowledge of GMPs and worldwide regulatory guidelines.
• Knowledge of CAPA procedures, specs, regulations and standards.
• Microsoft Office proficiency (Word/Excel/PowerPoint/Outlook).
• Strong communication, leadership and problem-solving skills.
• Ability to analyze ambiguous data using scientific principles.

Responsibilities

• Lead and execute investigations for deviations, documenting results per cGMP.
• Draft, revise and approve SOPs and controlled documents.
• Support production teams through troubleshooting, process optimization and documentation accuracy.
• Assist audits by clearly communicating findings and supporting data.
• Review data to identify trends, reduce downtime, improve yield and operator efficiency.
• Partner with Process Engineers and Operational Excellence teams to drive improvements.

Skills

Technical writing

Regulatory knowledge

Leadership

Communication

Problem solving

Veeva experience

Education

BS degree in science/technical field

Tools

Veeva

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Science and Compliance Specialist to provide technical guidance on aseptic practices and equipment. You will draft SOPs, support production through troubleshooting, and lead end-to-end deviation investigations while maintaining cGMP records. The role requires strong CAPA execution and audits support.

Schedule: Friday-Sunday 7:00am-7:30pm. Benefits include Day One Medical & Dental, FSA options, life insurance, 401(k) matching, and more.