Quality Assurance Analyst I — GMP Batch Review

Simtrabps; Bloomington (IN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 0%

Paid Holidays

Paid Time Off

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Analyst I to join the QA team in Bloomington, Indiana. You will review GMP batch records, reconcile discrepancies, and support timely release and disposition of products.

The role emphasizes collaboration with Production, QA, and regulatory bodies to maintain high quality and compliance standards. Requirements include a Bachelor's degree and experience in pharmaceutical quality or manufacturing, with proficiency in MS Word/Excel/Outlook and

Qualifications

• Bachelor's degree required or equivalent.
• Experience in Pharmaceutical Quality or Manufacturing preferred.
• Proficient 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.
• Reconcile discrepancies with documentation and/or electronic systems.
• Foster collaboration between Quality Assurance, Production and other functions to ensure timely batch record review and release.
• Initiate deviation investigation reports.
• Participate in continuous improvement projects to enhance quality and efficiency.
• Perform final batch record review, product release and disposition of GMP batches.
• May interact with clients or regulatory agencies.

Skills

Quality Assurance

GMP

Documentation Control

Education

Bachelor's degree in related field

Tools

Microsoft Word

Excel

Outlook

Veeva

D365

Trackwise

Job description

Simtra BioPharma Solutions is seeking a Quality Analyst I to join the QA team in Bloomington, Indiana. You will review GMP batch records, reconcile discrepancies, and support timely release and disposition of products.

The role emphasizes collaboration with Production, QA, and regulatory bodies to maintain high quality and compliance standards. Requirements include a Bachelor's degree and experience in pharmaceutical quality or manufacturing, with proficiency in MS Word/Excel/Outlook and