QA Batch Release Analyst II – Precision & Impact

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Medical & Dental Coverage

Flexible Spending Accounts

Life and AD&D Insurance

401(k) Retirement Savings Plan with 1:

Time Off Program

Education Assistance Program

Employee Assistance Program

Employee Ownership Plan

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst II to join the QA team. The role focuses on reviewing batch records and releasing GMP batches, coordinating with support functions to meet internal and contractual timelines.

You will mentor less experienced staff, drive continuous improvement projects, and ensure compliance with regulatory requirements. This is a hands-on QA position with opportunities for cross-functional collaboration and career growth.

Qualifications

• Bachelor’s degree in a science field with a minimum of 2 year Pharmaceutical Quality or Manufacturing experience, or Bachelor’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Master’s degree in a science field with a minimum of 1 year Pharmaceutical Quality or Manufacturing experience, or Master’s degree in non-science field with at least 5 years of Pharmaceutical Quality or Manufacturing experience.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Trackwise, etc.)

Responsibilities

• Perform batch record review and final product release / disposition for GMP batches produced at Simtra for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Plan, organize, evaluate, and communicate applicable activities of designated QA batch review functions, including Quality metrics reporting.
• Initiate and Author batch record related Deviations.
• Perform verification of Hold System activities.
• Reconcile controlled forms in the Veeva system.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
• Participate in raised client issue resolution (conference calls, responding to batch record observations)
• Subject Matter Expert for Batch Release procedures and presenting performed batch records during client and regulatory audits as required.
• Mentor and train less experienced Batch Review/Release personnel
• Lead continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.

Skills

Quality Assurance

Documentation review

Interdepartmental communication

Mentoring

Continuous improvement

Education

Bachelor’s degree in science

Bachelor’s degree in non-science with 5+ years

Master’s degree in science

Master’s degree in non-science with 5 years

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

D365

Veeva

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks a Quality Analyst II to join the QA team. The role focuses on reviewing batch records and releasing GMP batches, coordinating with support functions to meet internal and contractual timelines.

You will mentor less experienced staff, drive continuous improvement projects, and ensure compliance with regulatory requirements. This is a hands-on QA position with opportunities for cross-functional collaboration and career growth.