QA Batch Release Analyst II - Drive Quality & Compliance

Simtra US LLC; 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 2%

Paid Time Off

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst II to join the QA team. You will review batch records, ensure GMP compliance, and communicate with production and customer support to meet release targets.

The role emphasizes mentoring less experienced staff, leading improvement projects, and presenting batch records during audits while maintaining high quality and safety standards.

Qualifications

• Candidate has a science or non-science degree with requisite pharma QA/manufacturing experience.
• Proven ability to review batch records and release GMP batches.
• Strong communication, leadership and mentoring capabilities for cross-functional teams.

Responsibilities

• Perform batch record review and final product release for GMP batches.
• Reconcile discrepancies with documentation and electronic systems.
• Plan, organize and report QA batch review activities and metrics.
• Initiate and author batch record related deviations.
• Mentor and train less experienced Batch Review/Release personnel.
• Lead continuous improvement projects to improve efficiency and quality.

Skills

Quality Assurance

Batch Review

Leadership

Mentoring

Communication

Regulatory Knowledge

Education

Bachelor's degree in science

Bachelor's degree in non-science + 5y pharma experience

Master's degree in science

Master's degree in non-science + 5y pharma experience

Tools

Microsoft Word

Excel

Outlook

D365

Veeva

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst II to join the QA team. You will review batch records, ensure GMP compliance, and communicate with production and customer support to meet release targets.

The role emphasizes mentoring less experienced staff, leading improvement projects, and presenting batch records during audits while maintaining high quality and safety standards.