Aseptic Compliance Investigator & SOP Expert

Simtra US LLC

Bloomington (IN)

On-site

USD 75,000 - 110,000

Full time

14 days+

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Benefits offered by this job

Medical & Dental Coverage

401(k) with Company Match

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions (Simtra) in Bloomington, IN, seeks a Science and Compliance Specialist to provide aseptic operations expertise, draft SOPs, and support production with troubleshooting and CAPA implementation. You will lead investigations for deviations, ensure cGMP records, and partner with Process Engineers to drive continuous improvements while supporting audits.

This role requires a BS in science, 2+ years writing experience, GMP knowledge, and strong problem-solving and leadership

Qualifications

BS degree in science/technical field or equivalent aseptic pharmaceutical manufacturing experience.
2+ years technical writing experience, preferably in pharmaceutical industry.
Must have knowledge of GMPs and worldwide regulatory agency guidelines.

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 and improve 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 and regulatory compliance.