Quality Assurance Associate, On the Floor (Off Shift)-2
Elanco
12 days ago
On-site
Fort Dodge, IA
Operations
Your Role: Quality Assurance Associate, On the Floor (OTF)
Shift: Flexible based on availability; will cover some 2nd and 3rd shift hours Monday–Friday.
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; create or revise procedures as changes occur.
- Review and approve product batch records and technical documentation tied to validation, deviations, and change control (e.g., media fills).
- Determine root cause for deviation/CAPA reports and communicate outcomes to the Process Team.
- Develop training plans and train/qualify others (including training outside the immediate area).
- Demonstrate understanding of regulations for various countries and provide input/approval as needed.
Minimum Requirements:
- BS in a relevant scientific discipline with 2+ years quality assurance or biological production experience OR High School Diploma/GED with 5+ years relevant experience.
- Previous experience with USDA/FDA regulatory requirements in a biological production environment.
- Proficiency with Microsoft suite and other electronic applications such as SAP and Veeva; Learning One Source (or similar).
Preferences:
- Ability to make decisions with minimal supervision on product acceptability based on documentation.
- Excellent attention to detail.
- Professional interactions with internal and external customers.
- Ability to formulate ideas to improve site performance/efficiency and implement them across all levels.
Benefits:
- Multiple relocation packages (eligible positions)
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- Annual bonus offering
- Up to 6% 401(k) matching
Shift: Flexible based on availability; will cover some 2nd and 3rd shift hours Monday–Friday.
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; create or revise procedures as changes occur.
- Review and approve product batch records and technical documentation tied to validation, deviations, and change control (e.g., media fills).
- Determine root cause for deviation/CAPA reports and communicate outcomes to the Process Team.
- Develop training plans and train/qualify others (including training outside the immediate area).
- Demonstrate understanding of regulations for various countries and provide input/approval as needed.
Minimum Requirements:
- BS in a relevant scientific discipline with 2+ years quality assurance or biological production experience OR High School Diploma/GED with 5+ years relevant experience.
- Previous experience with USDA/FDA regulatory requirements in a biological production environment.
- Proficiency with Microsoft suite and other electronic applications such as SAP and Veeva; Learning One Source (or similar).
Preferences:
- Ability to make decisions with minimal supervision on product acceptability based on documentation.
- Excellent attention to detail.
- Professional interactions with internal and external customers.
- Ability to formulate ideas to improve site performance/efficiency and implement them across all levels.
Benefits:
- Multiple relocation packages (eligible positions)
- Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
- 8-week parental leave
- Annual bonus offering
- Up to 6% 401(k) matching