Risk Management Associate II — Pharma Quality & Compliance

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Plan

Paid Holidays

Paid Time Off

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Associate II (Risk Management) to lead risk assessment and change control activities at the site. You will interact with clients, regulatory agencies and cross-functional teams to ensure timely approval of documents. This role reports to the Technical Services Validation Sr.

Manager. You will guide regulatory compliance, assess risks, author risk assessments for equipment and process changes, and support ongoing CAPA

Qualifications

• Bachelor’s degree in science or engineering required.
• Minimum of 2 years pharmaceutical parenteral manufacturing experience.
• CQE/CMQ/OE or Six Sigma certification a plus.
• Proficiency with Microsoft Word, Excel, Outlook and enterprise software.

Responsibilities

• Provide guidance on regulatory requirements and risk management processes.
• Assess risks for non-conformances, complaints, audits, and change controls; update FMEAs.
• Review and approve risk assessments for equipment, processes, and facility changes.
• Lead risk management activities for engineering, manufacturing and process improvement projects.
• Serve as site SME for risk management and remediation guidance.
• Support risk assessments for new processes and validation projects.
• Utilize statistical tools to analyze risk and process data.
• Perform annual site FMEA reviews and CAPA/Change Control management.

Skills

Parenteral manufacturing

Quality management

Regulatory knowledge

Risk assessment

Education

Bachelor’s degree in science/engineering

Tools

JDE

Pilgrim

Veeva

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a Technical Services Associate II (Risk Management) to lead risk assessment and change control activities at the site. You will interact with clients, regulatory agencies and cross-functional teams to ensure timely approval of documents. This role reports to the Technical Services Validation Sr.

Manager. You will guide regulatory compliance, assess risks, author risk assessments for equipment and process changes, and support ongoing CAPA