Aseptic GMP Investigations Specialist

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

Time Off Program

Education Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Science and Compliance Specialist to serve as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs, and supporting production teams through troubleshooting, process optimization, and documentation accuracy.

The position also leads end-to-end investigations for deviations, applying structured problem-solving to identify root causes and drive CAPA implementation.

Qualifications

• BS degree in science or a technical field, or equivalent aseptic pharma manufacturing experience.
• 2+ years of technical writing experience in the pharmaceutical industry.
• Knowledge of GMPs and worldwide regulatory guidelines.
• Ability to draft, revise SOPs and controlled documents with accuracy.
• Strong communication and leadership skills; attention to detail.

Responsibilities

• Lead investigations for deviations using structured problem-solving and document results per cGMP.
• Define and analyze investigation elements and utilize appropriate tools.
• Identify root causes and document findings; maintain accurate lifecycle records.
• Collaborate on CAPA plans and verify effectiveness.
• Represent operations during audits with clear explanations and data.
• Review data to identify trends and drive process improvements and efficiency.
• Draft and approve SOPs and controlled documents for regulatory compliance.

Skills

Technical writing

GMP knowledge

Problem solving

Leadership

Communication

Detail orientation

Project management

Education

BS in science/technical field

Tools

Veeva

Microsoft Office

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Science and Compliance Specialist to serve as an operations SME, providing technical guidance on aseptic practices and equipment, drafting and revising SOPs, and supporting production teams through troubleshooting, process optimization, and documentation accuracy.

The position also leads end-to-end investigations for deviations, applying structured problem-solving to identify root causes and drive CAPA implementation.