Aseptic Operations & Compliance Specialist

Simtrabps; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Science and Compliance Specialist to lead aseptic investigations, draft SOPs, and support production teams with troubleshooting and CAPA implementation in a cGMP environment.

You will manage multiple investigations, communicate findings during audits, and partner with process engineers to improve safety, quality, and efficiency. This role requires 2+ years writing in pharma and a BS in science or tech.

Qualifications

• BS degree in science or technical area or equivalent aseptic pharmaceutical manufacturing experience.
• 2+ years technical writing experience, preferably in pharmaceutical industry.
• Knowledge of GMPs and worldwide regulatory agency guidelines.
• Knowledge of applicable CAPA procedures, specifications, regulations and standards.
• Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) intermediate proficiency.
• Strong oral and written communication skills.
• Ability to demonstrate strong leadership skills.

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 the root cause(s) of the issue and document the 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 support verification of CAPA effectiveness
• Manage multiple investigations simultaneously, ensuring timely progression and compliance with deadlines
• Represent operations during audits and inspections by clearly explaining investigation scope, rationale, findings, and supporting data
• Review and analyze operational data to identify trends, recurring issues, and opportunities to reduce downtime, increase yield, and improve operator efficiency
• Partner with Process Engineers and Operational Excellence teams to champion improvements that enhance safety, quality, efficiency, and overall process 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, clarity, and regulatory compliance

Skills

Problem-solving

Leadership

Communication

GMP knowledge

Time management

Analytical thinking

MS Office

Cross-functional collaboration

Education

Bachelor's degree in science/technical field

Tools

Veeva

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Science and Compliance Specialist to lead aseptic investigations, draft SOPs, and support production teams with troubleshooting and CAPA implementation in a cGMP environment.

You will manage multiple investigations, communicate findings during audits, and partner with process engineers to improve safety, quality, and efficiency. This role requires 2+ years writing in pharma and a BS in science or tech.