Aseptic Compliance Specialist & CAPA Lead

Simtrabps; Bloomington (IN); On-site; USD 80,000 - 105,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Paid Holidays

Paid Time Off

Parental Leave and more

Job summary

Simtra BioPharma Solutions, based in Bloomington, IN, seeks a Science and Compliance Specialist to guide aseptic practices, draft SOPs, and support production teams with troubleshooting and documentation accuracy. The role leads end-to-end deviations investigations and supports audits within a cGMP environment.

You'll manage multiple investigations, apply root-cause analysis, implement CAPA plans, and collaborate with Process Engineers to improve safety, quality, and efficiency.

Qualifications

• BS degree in science/technical area or equivalent aseptic pharma manufacturing experience.
• 2+ years technical writing experience, preferably in pharmaceutical industry.
• Knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of CAPA procedures, specifications, regulations and standards.
• Strong communication and leadership skills.
• Proficiency with MS Office and enterprise software (Veeva).

Responsibilities

• Lead and execute investigations for deviations, including defining scope, applying structured problem‑solving methods, and documenting results in compliance with cGMP standards.
• Determine the Define/Measure/Analyze elements of the investigation by utilizing investigation tools.
• Investigate root causes and document investigation results.
• Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle.
• Collaborate with Action Owners to create effective CAPA plans and verify CAPA effectiveness.
• Manage multiple investigations simultaneously, ensuring timely progression and deadlines.
• Represent operations during audits and inspections by explaining scope, rationale, findings and data.
• Review and analyze operational data to identify trends and opportunities to reduce downtime, increase yield, and improve efficiency.
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and performance.
• Serve as an operations SME, providing technical guidance on process performance, aseptic practices, and equipment operation.
• Draft, revise, and approve SOPs and other controlled documents to ensure accuracy and regulatory compliance.

Skills

Strong communication

Leadership

Problem solving

Time management

Critical thinking

Goal setting

Attention to detail

Education

BS degree in science/technical

Tools

Microsoft Office Suite

Veeva

Job description

Simtra BioPharma Solutions, based in Bloomington, IN, seeks a Science and Compliance Specialist to guide aseptic practices, draft SOPs, and support production teams with troubleshooting and documentation accuracy. The role leads end-to-end deviations investigations and supports audits within a cGMP environment.

You'll manage multiple investigations, apply root-cause analysis, implement CAPA plans, and collaborate with Process Engineers to improve safety, quality, and efficiency.