Quality Analyst I – Batch Release & Documentation

Simtra US LLC; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Retirement Savings Plan with 2+

Time Off Program

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions, based in Bloomington, Indiana, is seeking a Quality Analyst I Batch Release to join the QA team. You will compile manufacturing documentation, print controlled forms, and manage batch record sign-out/in, supporting correction processes and ERP systems.

The role requires a science degree or equivalent experience, strong QA understanding, and proficiency with Word/Excel/Outlook plus enterprise software.

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. This may include supplemental batch record sections, controlled forms, and documents of other types.
• Manage the process of sign-out and sign-in of batch records.
• Manage the process of correction resolution, assisting personnel with controlled access to executed records requiring documentation corrections.
• Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions to ensure on-time Quality review of batch records in order 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.

Skills

Quality Assurance

Organizational skills

Problem solving

Education

Bachelor's degree in science

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions, based in Bloomington, Indiana, is seeking a Quality Analyst I Batch Release to join the QA team. You will compile manufacturing documentation, print controlled forms, and manage batch record sign-out/in, supporting correction processes and ERP systems.

The role requires a science degree or equivalent experience, strong QA understanding, and proficiency with Word/Excel/Outlook plus enterprise software.