GMP Quality Analyst I: Batch Review & Release

Simtra US LLC; 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 公司

Time Off Program

Education Assistance Program

Employee Assistance Program

Employee Ownership Plan

Job summary

Simtra US LLC in Bloomington, Indiana is seeking a dedicated Quality Analyst I to join the Quality Assurance Team. You will review batch records generated during filling or packaging, ensuring accuracy and regulatory compliance, and coordinate with customer support to resolve issues.

You will collaborate with Production and QA to meet release timelines, initiate deviation investigations, and support continuous improvement projects to enhance quality and efficiency.

Qualifications

• Bachelor's degree required.
• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Proficient with Word, Excel, Outlook and enterprise software (Veeva, D365, Trackwise).

Responsibilities

• Perform batch record review for GMP batches produced at Simtra for accuracy and compliance.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Facilitate communication between QA, Production and other support functions to ensure timely batch review and release.
• Initiate deviation investigation reports.
• Participate in continuous improvement projects to enhance quality and efficiency.
• Perform final batch record review, product release/disposition of GMP batches.
• May require client or Regulatory Agency interaction.

Skills

GMP knowledge

Attention to detail

Education

Bachelor's degree

Tools

Veeva

D365

Trackwise

MS Office

Job description

Simtra US LLC in Bloomington, Indiana is seeking a dedicated Quality Analyst I to join the Quality Assurance Team. You will review batch records generated during filling or packaging, ensuring accuracy and regulatory compliance, and coordinate with customer support to resolve issues.

You will collaborate with Production and QA to meet release timelines, initiate deviation investigations, and support continuous improvement projects to enhance quality and efficiency.