Quality Analyst I - Batch Release (Weekend PM)

Simtra US LLC; Bloomington (IN); Hybrid; USD 55,000 - 65,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 公司

Time Off Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Quality Analyst I – Batch Release for weekend PM shifts to compile batch docs, print controlled forms, and manage batch record sign-out/in. You will support correction resolution and coordinate with QA, Production, and Documentation Centers.

The role requires a science degree or equivalent pharma QA experience, with knowledge of FDA-regulated processes and aseptic operations. Friday–Sunday, 7:00p–7:30a shift is offered.

Qualifications

• Bachelor's degree in science or an equivalent combination with pharma QA experience.
• Understanding of quality assurance in an FDA-regulated environment and aseptic processing.
• Strong organizational, technical and problem-solving skills.
• Proficient with Word, Excel, Outlook and enterprise software

Responsibilities

• Perform final batch record review
• Reconcile discrepancies with documentation and/or electronic systems
• Compile documentation packets for batch manufacturing and printing of controlled forms
• Generate additional batch documents for batches in progress as needed
• Manage the sign-out and sign-in of batch records
• Support correction resolution and access controls for executed records
• Collaborate with QA, Production and other functions to ensure on-time batch release

Skills

Quality Assurance

Organizational skills

Problem-solving

MS Word

Excel

Outlook

Education

Bachelor's degree in science

Bachelor's degree in non-science with 3+ years pharma QA experience

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana, seeks a Quality Analyst I – Batch Release for weekend PM shifts to compile batch docs, print controlled forms, and manage batch record sign-out/in. You will support correction resolution and coordinate with QA, Production, and Documentation Centers.

The role requires a science degree or equivalent pharma QA experience, with knowledge of FDA-regulated processes and aseptic operations. Friday–Sunday, 7:00p–7:30a shift is offered.