Quality Analyst II - Batch Release & QA Lead

Simtrabps; Bloomington (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with CD

Paid Time Off and Holidays

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Analyst II to join the Quality Assurance team. You will review batch records, ensure GMP compliance, and coordinate with QA, Production and support functions to meet release deadlines.

The role requires a science-based degree with QA/Manufacturing experience and proficiency in enterprise software (D365, Veeva, Trackwise). You will mentor junior staff and lead continuous improvement initiatives to enhance quality and

Qualifications

• Bachelor’s degree in a science field with a minimum of 2 years 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.
• 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 teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records to meet targets and commitments.
• Participate in raised client issue resolution and respond 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 satisfaction.

Skills

Quality Assurance

Batch Review

Documentation review

Leadership

Communication

Education

Bachelor's degree in science with QA/Manufacturing experience

Master's degree in science with QA/Manufacturing experience

Bachelor's degree in non-science with QA/Manufacturing experience

Master's degree in non-science with QA/Manufacturing experience

Tools

D365

Veeva

Trackwise

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a Quality Analyst II to join the Quality Assurance team. You will review batch records, ensure GMP compliance, and coordinate with QA, Production and support functions to meet release deadlines.

The role requires a science-based degree with QA/Manufacturing experience and proficiency in enterprise software (D365, Veeva, Trackwise). You will mentor junior staff and lead continuous improvement initiatives to enhance quality and