Quality Assurance Associate, On the Floor (2nd shift 4PM-2:30AM)

Scorpion Therapeutics; Fort Dodge (IA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Relocation packages (eligible)

Two weeklong shutdowns in the US

8-week parental leave

9 Employee Resource Groups

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is seeking a Quality Assurance Associate, On the Floor (OTF) for the 2nd shift (4PM–2:30AM) in Fort Dodge, Iowa. You will support Process Teams by tracking, reporting, and defining continuous improvement goals, review on-the-floor batch records, determine root causes for deviations, and write investigation reports.

You will coach/train personnel on GMP/GDP to maintain production quality. You will audit production processes for compliance with global and local procedures, review/approve

Qualifications

• Associate’s or Bachelor’s degree in a science-related field with relevant industry experience.
• Experience with USDA/FDA regulatory requirements in a biological production environment.
• Experience with computer programs such as Microsoft suite, SAP, Veeva, Learning One Source, and other relevant electronic applications.

Responsibilities

• Support Process Teams by tracking/reporting and defining continuous improvement goals.
• Review on-the-floor batch records; determine root cause for deviations; write investigation reports.
• Coach/train personnel on GMP/GDP.
• Audit production processes for compliance with global and local procedures.
• Review/approve product batch records and technical documentation for validation, deviations, and change control (e.g., media fills).
• Track/report and define continuous improvement goals; determine root cause for deviations/CAPA reports and communicate back to the Process Team.
• Create new or revise existing procedures as changes occur.
• Develop training plans and train/qualify others (including training outside area of responsibility).
• Provide input/approval based on understanding of regulations for various countries.

Education

Associate’s degree in a science-related field with relevant industry experience, or Bachelor’s degree in a science-related field (e.g., Biology, Chemistry)

Experience with USDA/FDA regulatory requirements in a biological production environment

Tools

Microsoft Office

SAP

Veeva

Learning One Source

Job description

Quality Assurance Associate, On the Floor (OTF)

Shift: 2nd shift 4PM–2:30AM

Responsibilities:

• Support Process Teams by tracking/reporting and defining continuous improvement goals.
• Review on-the-floor batch records; determine root cause for deviations; write investigation reports.
• Coach/train personnel on GMP/GDP.
• Audit production processes for compliance with global and local procedures.
• Review/approve product batch records and technical documentation for validation, deviations, and change control (e.g., media fills).
• Track/report and define continuous improvement goals; determine root cause for deviations/CAPA reports and communicate back to the Process Team.
• Create new or revise existing procedures as changes occur.
• Develop training plans and train/qualify others (including training outside area of responsibility).
• Provide input/approval based on understanding of regulations for various countries.

Minimum Requirements:

• Associate’s degree in a science-related field with relevant industry experience, or Bachelor’s degree in a science-related field (e.g., Biology, Chemistry).
• Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Experience with computer programs such as Microsoft suite, SAP, Veeva, Learning One Source, and other relevant electronic applications.

Preferences:

• Ability to make product acceptability decisions with minimal supervision based on documentation.
• Excellent attention to detail.
• Strong professionalism with internal and external customers.
• Ability to formulate ideas to improve site performance/efficiency and implement collaboratively.

Elanco Benefits and Perks:

• Multiple relocation packages (eligible positions)
• Two weeklong shutdowns in the US (mid-summer and year-end) in addition to PTO
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Up to 6% 401K matching