Quality Analyst I - Batch Review & Release

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 52,000 - 68,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Plan with Company匹配

Time Off Program

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Analyst I to join the QA Batch Review team in Bloomington, Indiana. The role involves reviewing GMP batch records, ensuring accuracy and compliance with procedures, and coordinating with QA, Production, and support groups to meet release timelines.

The ideal candidate has experience in pharmaceutical quality or manufacturing and proficiency with Microsoft Office and enterprise software such as Veeva, D365, or TrackWise.

Qualifications

• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Proficient in Microsoft Word, Excel, Outlook; familiar with enterprise software (Veeva, D365, TrackWise).

Responsibilities

• Perform batch record review 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.
• Facilitate an environment of partnership and communication between QA, Production and other support functions to ensure timely quality review of batch records to achieve internal targets and contractual commitments for batch release.
• Participate in continuous improvement projects to improve department operations, increase efficiency, solve problems, generate cost savings, improve quality, and increase employee and customer satisfaction.
• Perform final batch record review, product release / disposition of GMP batches produced at Simtra.
• May require client or Regulatory Agency interaction

Skills

Quality assurance

Manufacturing quality

MS Office

Tools

Veeva

D365

TrackWise

Job description

Simtra BioPharma Solutions is seeking a Quality Analyst I to join the QA Batch Review team in Bloomington, Indiana. The role involves reviewing GMP batch records, ensuring accuracy and compliance with procedures, and coordinating with QA, Production, and support groups to meet release timelines.

The ideal candidate has experience in pharmaceutical quality or manufacturing and proficiency with Microsoft Office and enterprise software such as Veeva, D365, or TrackWise.