Quality Analyst I, Batch Release (Night Shift)

Simtrabps; Bloomington (IN); On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan

Paid Time Off

Education Assistance Program

Employee Assistance Program

Flexible Spending Accounts

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Analyst I Batch Release to join the Quality Assurance team. This role compiles documentation for batch manufacturing, prints controlled forms from Veeva, and manages batch record sign-in/out.

The role requires a Bachelor’s degree in science with at least three years in Pharma QA or manufacturing, familiarity with aseptic processing, and strong organizational skills.

Qualifications

• Bachelor’s degree in a science discipline or bachelor’s degree in non-science discipline with at least three years of Pharmaceutical Quality or Manufacturing experience.
• Demonstrated understanding of quality assurance in an FDA-regulated environment and aseptic processing operations.
• Effective organizational, technical and problem-solving skills.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Responsibilities

• Perform final batch record review.
• Reconcile discrepancies with documentation and/or electronic systems as appropriate.
• Compile documentation packets for batch manufacturing, including printing of controlled forms and other serialized or controlled documentation that is not part of the effective manufacturing batch record.
• As needed during operations, generate additional batch documents for batches in progress.

Skills

Quality Assurance understanding

Aseptic processing

Organizational skills

Problem solving

Microsoft Word/Excel/Outlook

Education

Bachelor’s degree in science or related field

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking a Quality Analyst I Batch Release to join the Quality Assurance team. This role compiles documentation for batch manufacturing, prints controlled forms from Veeva, and manages batch record sign-in/out.

The role requires a Bachelor’s degree in science with at least three years in Pharma QA or manufacturing, familiarity with aseptic processing, and strong organizational skills.