Aseptic Compliance & Investigations Specialist

Inuplands; Bloomington (IN); Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Paid Time Off

Parental Leave

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Science and Compliance Specialist to guide aseptic practices, draft SOPs, and support production through investigations and CAPA implementation. The role requires leading end-to-end investigations, resolving deviations, and maintaining compliant records in a fast-paced manufacturing setting.

The position involves collaboration with process engineers and operations, audits support, and driving process improvements for safety, quality, and

Qualifications

• BS degree in science or technical field, or equivalent aseptic pharmaceutical manufacturing experience.
• 2+ years of technical writing experience, preferably in pharmaceutical industry.
• Knowledge of GMPs and worldwide regulatory guidelines.
• Knowledge of CAPA procedures, specifications, regulations and standards.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Strong organization, time management and communication skills.
• Experience with FDA regulations and GMP application.
• Ability to use enterprise software (Veeva).

Responsibilities

• Lead and execute investigations for deviations, defining scope and applying structured problem‑solving methods.
• Determine elements of the investigation using defined tools.
• Investigate root causes and document results.
• Maintain accurate investigation records throughout lifecycle.
• Collaborate on CAPA plans and verify effectiveness.
• Manage multiple investigations with deadlines.
• Represent operations during audits and inspections with clear data.
• Analyze operational data to identify trends and improvements.
• Partner with Process Engineers to drive safety, quality and efficiency.
• Draft and approve SOPs and controlled documents.

Skills

Technical writing

GMP knowledge

MS Office

Leadership

Problem solving

Education

BS degree in sciences/technical field

Tools

Veeva

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Science and Compliance Specialist to guide aseptic practices, draft SOPs, and support production through investigations and CAPA implementation. The role requires leading end-to-end investigations, resolving deviations, and maintaining compliant records in a fast-paced manufacturing setting.

The position involves collaboration with process engineers and operations, audits support, and driving process improvements for safety, quality, and