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As a Quality Associate at our Fort Dodge manufacturing site you will:
1). Deviations and CAPA:
- Identifies issues and reports events per Elanco procedures.
- Participates in investigation teams to identify root cause/CAPA.
- Provides quality support to the hub warehouse operations regarding compliant documentation approaches involving deviations, CAPA and complaints.
- Ensures prompt resolution of quality issues.
- On time completion of quality reports reflected in metrics; reports are clearly written and include the key elements required in complaint investigations per the quality standard.
- CAPAs are completed by target due dates.
2). Quality support of Packaging and Labeling operations
- Follows SOPs and inspection requirements for packaging component and labeling quality control
- Proactively identifies quality/compliance risks and resolves issues
- Ensures overall quality of Fort Dodge packaging and labeling operations.
- Ensures label control and packaging operations are in compliance with site SOPs, Elanco functional procedures and Elanco Quality standards.
3). Material Control
- Provides quality support of material handling, storage and control.
- Ensures compliance with Elanco requirements for lot status assignment, inventory control and segregation and security of rejected material.
4). Supplier Quality
- Executes supplier quality program: identifies compliance risks, develops risk mitigation strategies and ensures commitments are tracked and met.
- Coordinates with EGQCA in the development of the annual supplier audit plan.
- Conducts periodic reviews of supplier quality agreements.
- Coordinates with procurement, R&D and site operations in the selection and approval of new suppliers
- Requests and reviews supplier investigations in support of investigations into non-conforming materials.
- Reviews supplier change notifications and performs impact assessments.
- Maintains strategic partnership with suppliers and logistics providers
- Ensures the quality of incoming materials, materials released are compliant to the approved specification.
- Ensures requirements around testing for materials of animal origin are identified and implemented.
- Ensures compliance with Elanco quality system requirements for training.
- Completes own assigned training by target due dates
- Identifies professional development opportunities for self and team.
- Ensures on time completion of training
- Routinely monitors assignments in learning system to assure training is always up to date. Training is completed on time and by due dates.
- Proactively identifies training opportunities
- Ensures training is completed prior to performing work
- Participates in and may lead project teams in alignment with site quality strategic direction
- Champions idea generation and solution development/process improvement.
- Provides data to support implementation and suggests new ways to apply existing knowledge.
- Displays respect and appreciation for individual differences; values contributions of others
- Well versed in all regulatory requirements, inclusive of cGMP/GLP
- Ability to plan, schedule, organize, prioritize, and coordinate activities.
- Makes routine decisions with limited guidance from supervisor.
- Recognizes and reacts to the significance of data/results.
- Written and verbal communication.
- Must be self-motivated and of high integrity
- Ability to use technical knowledge to solve problems.
- Demonstrated high ethical and professional standards
- Proficiency in relevant computer software programs associated with the area
A BS degree in a scientific discipline
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status