Quality Auditor - Scientific - I (Assistant)

TALENT Software Services; Omaha (NE); On-site; USD 34,000 - 48,000; Full time

Job summary

TALENT Software Services in Elkhorn, NE seeks a QA Contractor to support manufacturing operations and perform batch record reviews in a clean lab environment. The role involves collaboration with QA, IPTs, and production teams to ensure regulatory compliance with USDA/FDA standards and cGMP practices.

The ideal candidate will have a high school diploma with relevant experience, familiarity with vaccine manufacturing, and knowledge of GMP, QA systems, and SAP or similar platforms.

Qualifications

• H.S Diploma with minimum of 3 years of work history.
• H.S Diploma with 1 year of experience in similar industry.
• Degree in microbiology, chemistry, or similar scientific discipline.
• Familiarity and/or experience with vaccine manufacturing and/or testing
• Familiarity and/or experience with USDA and/or FDA regulations and inspections
• Experience in GMP and Quality Management Systems
• Familiarity and/or experience and experience with SAP or similar systems.

Responsibilities

• This role will support manufacturing operations and will be primarily responsible for the review of completed production batch documents.
• This role will be responsible for batch record review.
• Multiple departments of batch records will be in scope for this role.
• This team member will provide documentation guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.
• Document reviews will be tracked and prioritized based on target release dates and will assist the IPT in tracking and prioritizing their reviews to meet target dates.
• This includes regular communications to review status to groups both downstream and upstream of document review.
• The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday. This team member will assist with document archival tasks.
• This Quality Assurance Role will also work closely with the Upstream and Downstream IPTs, alongside other members of Quality Assurance to provide quality support in multiple ways including assisting in inspections, investigations and compliance actions assigned to the IPT.
• This team member will be located in a clean manufacturing lab environment. While approximately 80% of their role will be in an office setting, they will also be expected to regularly spend time within the manufacturing areas to learn processes, evaluate compliance and build relationships of trust with production operators and management.
• This position will also share a support role for the review and release of printed packaging and raw material components.
• This position is expected to become a back-up for various QA functions within the team as well as assist with quality systems tasks such as, deviations and change controls.
• The ideal candidate will seek opportunities to develop competency in the multiple Quality Assurance functions and systems and assist in various projects and responsiblies within the QA and manufacturing team.
• This role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization The ideal candidate will have attributes of critical thinking, problem solving and disciplined judgement which will allow them to excel on a specialized and dynamic Quality Assurance team.
• A successful candidate will be able to navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Education

H.S Diploma with minimum 3 years of work history

H.S Diploma with 1 year of experience in similar industry

Tools

SAP

Job description

QA Contractor

Minimum Education/Experience Requirement:

• H.S Diploma with minimum of 3 years of work history
• H.S Diploma with 1 year of experience in similar industry

Preferred Education, Experience and Skills:

• Degree in microbiology, chemistry, or similar scientific discipline.
• Familiarity and/or experience with vaccine manufacturing and/or testing
• Familiarity and/or experience with USDA and/or FDA regulations and inspections
• Experience in GMP and Quality Management Systems
• Familiarity and/or experience and experience with SAP or similar systems.

Work Location:

Elkhorn, NE

Shift Schedule:

First Shift (Can start as early as 06:30am but no later than 08:00am CST)

Position Description:

• This role will support manufacturing operations and will be primarily responsible for the review of completed production batch documents.
• This role will be responsible for batch record review.
• Multiple departments of batch records will be in scope for this role.
• This team member will provide documentation guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.
• Document reviews will be tracked and prioritized based on target release dates and will assist the IPT in tracking and prioritizing their reviews to meet target dates.
• This includes regular communications to review status to groups both downstream and upstream of document review.
• The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday. This team member will assist with document archival tasks.
• This Quality Assurance Role will also work closely with the Upstream and Downstream IPTs, alongside other members of Quality Assurance to provide quality support in multiple ways including assisting in inspections, investigations and compliance actions assigned to the IPT.
• This team member will be located in a clean manufacturing lab environment. While approximately 80% of their role will be in an office setting, they will also be expected to regularly spend time within the manufacturing areas to learn processes, evaluate compliance and build relationships of trust with production operators and management.
• This position will also share a support role for the review and release of printed packaging and raw material components.
• This position is expected to become a back-up for various QA functions within the team as well as assist with quality systems tasks such as, deviations and change controls.
• The ideal candidate will seek opportunities to develop competency in the multiple Quality Assurance functions and systems and assist in various projects and responsiblies within the QA and manufacturing team.
• This role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization The ideal candidate will have attributes of critical thinking, problem solving and disciplined judgement which will allow them to excel on a specialized and dynamic Quality Assurance team.
• A successful candidate will be able to navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Key participant in Quality Compliance Inspections from regulatory agencies and off-site entities
• Other tasks as assigned by QA Manager and Quality Director