As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals’ lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco’s promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.
The Bio Quality Control group is responsible for performing bio-analytical methods (immunological, in vivo, microbiological, molecular biological, or virologic) for various Bio QC tests on raw materials, in-process, release, or stability samples in compliance with 9CFR, EU and VICH regulatory guidelines, Outlines of Production and Special Outlines. The incumbent will initiate, execute, and complete assays as per approved procedures and within Quality and Compliance guidelines. The Sterility area also performs and maintains the area disinfection schedule as appropriate to the room Level. The incumbent is responsible for timely communication with managers to inform them of testing, compliance and/or scheduling issues, adhering to company policies, maintaining a safe work environment through Site safety KPIs, and following appropriate GMP documentation. Additional duties are based upon the incumbent’s level and experience. This position will perform all testing, cleaning, and aseptic assessments as required by area procedures, i.e.: working Supervisor.
Basic Minimum Requirements
- BS in a relevant scientific discipline
- Business and/or technical knowledge developed through education or past experience.
- Thorough understanding of bacterial culture maintenance, aseptic technique, and good laboratory practices.
- Thorough understanding of scientific concepts and principles and complex lab techniques. Ability to manage portions of major projects with supervision or minor projects independently.
- 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.
- Develop/validate methods and processes. Performs and documents work following established methods, SOP’s and/or GXP. Good understanding of applicable regulations and impact to project and/or business.
- Able to interact with regulatory agencies. Comprehensive understanding of processes in immediate area and familiarity of processes in other areas. Makes routine decisions with limited guidance from supervisor.
- Recognizes and reacts to the significance of data/results. Able to effectively communicate procedures, thoughts and ideas in a clear concise and appropriate manner within and outside of own department. Communicates with cross-functional groups.
- Documents and reviews lab results/data as required by applicable SOP’s and methods. Organizes data generated for inclusion in reports.
- Write and revise SOP’s, methods, and protocols. Works and interacts mainly within own group to complete tasks assigned.
- Able to train others on methods and routine lab work.
- Cooperates and shares information with other groups and departments to accomplish goals. Contributes original suggestions and acts independently to find answers and solutions.
- Ability and willingness to jump into the laboratory to help with ALL process and cleaning duties to ensure daily tasks are completed as required.
- Maintain inventories of reagents and supplies. Operate and maintain calibrated standard equipment. Maintain a clean and orderly lab.
- Conduct testing: Sterility, Mycoplasma, Potency, and numerous miscellaneous testing per method.
- Maintain disinfected and sanitized area by following specific room cleaning procedures.
- Perform testing using a significant portion of the existing laboratory assays.
- Prepare reagents and materials
- Calculates results.
- Communicates schedule, test status and concerns.
- Write Laboratory Investigations or deviations, and area reports, as needed.
- Writes change controls as needed.
- Review and approve results and test sheets for compliance to regulations.
- Enter results into SAP and/or complete second verification.
- Revise pre-existing Standard Methods and SOPs.
- Create New Standard Methods, SOPs, Protocols.
- Trains others on methods & procedures.
- Coordinate projects within group or department with little supervision using strategic planning.
- Coordinate projects with different departments with little supervision using strategic planning.
- Analytical thinking and problem-solving resolution.
- Understands complex situations, issues, or systems. Evaluate the impact of changes.
- Supervise small group of people, conduct routine performance discussions, maintain scheduling through adversity.
- Understand the complex nature of supervising and running a laboratory with outside limiting factors.
- 2-3 years relevant work experience (lab-work qualifies)
- Leadership experience is not required for this position.
- This individual is expected to interface, work with team members, and train colleagues, when necessary, with efforts within the Quality Control Team regardless of site and, but not limited to: R&D, Operations, Assay Development, BioProcess Science, Quality Assurance, Document Control and Supply Chain departments.
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