Quality Analyst I – GMP Batch Review & Release

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with Co

Education Assistance Program

Flexible Spending Accounts

Employee Assistance Program

Onsite Campus Amenities

Life and AD&D Insurance

Job summary

Simtra BioPharma Solutions is seeking a Quality Analyst I for Bloomington, IN to join its Quality Assurance team. The role focuses on reviewing batch records generated during filling or packaging operations and communicating with customer support departments.

The incumbent will reconcile discrepancies, liaise with QA, Production, and support functions to ensure timely batch reviews and batch release, and participate in continuous improvement projects to enhance quality and efficiency.

Qualifications

• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Proficiency with MS Word, Excel, Outlook and enterprise software (Veeva, D365, Trackwise).

Responsibilities

• Perform batch record review for GMP batches produced at Simtra for accuracy and compliance with procedures and regulatory requirements.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Foster partnership and clear communication between QA, Production and support functions to ensure timely batch reviews and release.
• Participate in continuous improvement projects to enhance operations, efficiency, quality and customer satisfaction.
• Perform final batch record review, product release/disposition of GMP batches produced at Simtra.
• May interact with clients or Regulatory Agencies as needed.

Skills

Quality experience

Tools

Veeva

D365

Trackwise

Job description

Simtra BioPharma Solutions is seeking a Quality Analyst I for Bloomington, IN to join its Quality Assurance team. The role focuses on reviewing batch records generated during filling or packaging operations and communicating with customer support departments.

The incumbent will reconcile discrepancies, liaise with QA, Production, and support functions to ensure timely batch reviews and batch release, and participate in continuous improvement projects to enhance quality and efficiency.