This individual will be responsible for auditing products for final disposition for the Elanco Fort Dodge site. This position assures that all specifications and Outline of Production requirements are met prior to each stage of release leading up to Form 2008 submissions to comply with USDA, and cGMP regulatory requirements. The scope of the support includes every state of manufacturing including products for 3rd party Contract Manufacturing.
Functions, Duties, Tasks:
Key Technical Responsibilities
- Perform batch audits and final disposition for manufactured products for compliance to cGMP
- Perform review and approval of executed batch records and test records
- Reviews and approved Certificates of Analysis and Certificates of Compliance for batch release.
- Creates CBRs/International permits for international release
- Perform Impact assessments on products to comply with USDA or other GMP regulatory requirements
- Review technical investigation reports detailing findings and product assessments
- Review and approve local SOPs, Test Specifications, QC Methods
- Performs review and approvals of APHIS Form 2008’s against applicable Outlines of Production for USDA release
- Ensure product documentation is complete and compliant with specifications, SOPs and regulations
- Submits product release data for monthly KPI and Metric reports
- Serve as a QA representative and SME on assigned internal and external project/process flow teams to solve quality related issues
- Assist with internal, regulatory and corporate audits to ensure compliance with regulations, quality standards and guidance documents
- Assist with audit responses and completion of assigned CAPAs by target due dates
- Influence as a technical resource and department SME for quality related topics
Minimum Qualification (education, experience and/or training, required certifications):
- Bachelor Degree in Science or related field
- Technically self-sufficient and proficient in the performance of batch audits, intermediate product release, understanding of Form 2008 USDA submissions
- Qualified candidates must be legally authorized to be employed in the United States.
- Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Excellent written and verbal communication skills, attention to detail and commitment to customer service
- Proficiency in relevant computer software programs associated with the area
- Ability to select, develop and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by Elanco
- Good understanding of the relevant USDA regulations
- Microsoft suite, SAP, VEEVA experience
- This is a fixed duration of two years with the possibility of extending up to four years
- Medical, vacation, 401K and relocation benefits available
- 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
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