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The purpose of this position is to support the site’s Technical Services / Material Sciences team and will perform, coordinate, and track annual Outline reviews (AORs) through interaction with the Regulatory Affairs team and TSMS subject matter experts ensuring compliance of the sites Manufacturing Directions. Confirms that the Outline of Production accurately reflects the manufacturing process performed on the floor documented in the Batch Records. Initiating any necessary Outline Revisions within the Quality Management System to reconcile.
Basic Minimum Qualifications:
- BS in a relevant scientific discipline required + 2 – 3 years relevant experience preferred.
- Work experience in USDA or regulated animal health industry is beneficial.
- Excellent written and verbal communication skills
- Attention to detail and commitment to customer service
- Concise and accurate review of technical data and information
- Ability to follow written procedures, SOPs, and other documents
- Ability to perform basic mathematical calculations are required.
- Demonstrated high ethical and professional standards
- Intermediate level understanding or exposure to manufacture of biological products
- Demonstrated ability to work within diversely populated teams and networks
- Qualified candidates must be legally authorized to be employed in the United States. Elanco Animal Health does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this position.
Scope of the Support Includes:
- Review and approval of relevant Manufacturing Direction revisions in the site document management system (VEEVA).
- Knowledge of animal health vaccine manufacturing processes to compare Manufacturing Direction revisions against the Outline of Production ensuring requirements are met within cGMP.
- Interaction with TSMS and Manufacturing subject matter experts for clarification, revision impact, and guidance as necessary.
The Position Will Also Assist With:
- Generation and status tracking of Process Flow Documents in accordance to approved functional procedures.
- Activity may include preparing initial document from template, compiling identifying protocol and report data by query of VEEVA, and assisting TSMS Scientists with preparing process flow charts from standardized templates.
- Is primary interface between Manufacturing Administrative staff initiating the Manufacturing Direction revisions and TSMS.
- Is primary interface between Regulatory Affairs staff initiating the AORs and TSMS.
- Ability to assess the appropriateness of regulated manufacturing processes and the technical documents associated with the manufacture of products by Elanco.
- May require manufacturing process observation for learning and development.
- Assists in improving Manufacturing Direction’s good documentation practices.
- Assists in improving the AOR process.
- Performs the duties within TSMS with minimal supervision.
- Interface within Technical Services Material Sciences (TSMS) Team along with Regulatory Affairs, Manufacturing, Quality Control, Quality Assurance, and Document Control.
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