Assistant I-QA Operations-FDE
?Company Overview:Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.Responsibilities:?? ?Perform In-Process checks and Line Cleaerances of the manufacturing operations.Responsible for administering the Retain Sample ProgramPerforms AQL sampling of incoming components. (i.e. labels, pre-printed cartons, components)Performs testing of incoming goods per the appropriate Standard Operating Procedures.Monitors routine line clearance activities. ?Schedules activities in cooperation with manufacturing in order to meet production plans.Continuous monitoring of manufacturing processes to ensure compliance to Standard Operating Procedures.Performs sampling, inventory, storage and annual inspection of Active Pharmaceutical Ingredients (APIs) and Finished Product retain samples.Inspection of Quality Managed MRO materials (e.g., sterile gowning supplies)Assist plant personnel with request for copies of documentation (Batch Records)Partner with Manufacturing to assure compliance to SOPs, Specifications and Batch Records.Perform other laboratory tasks as need (e.g. FTIR, Blue Dye Preparation)Ability to manage change productively, work independently and multi-task as assigned.Basic Qualifications:?? ?High school diploma/GED?Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.?Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.Additional Skills/Preferences:?? ?Experience in the use of computer technology within QA systemsGood communication, planning and organization skillsAbility to work in a team environment. ?Demonstrated team approach to multidiscipline issues relating to qualityAssociates Degree in Life Sciences (Biology, Chemistry, etc.), or in a technical area related to the pharmaceutical industry or three (3) years equivalent work experience is preferred.Experience in Pharmaceutical or a Healthcare related industryKnowledge of cGMP's and other regulatory standards for Active Pharmaceutical Ingredients and Finished Product dosage formsExperience in the use of computer technology with regards to SAP and its interactions with a manufacturing facility preferred?Additional Information:?? ?Ability to lift 50 lbsStand for an extended period of timeMust be able to work rotating shifts as necessaryThis position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.?Lilly 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.?Removal Date: 26-Jan-2017Apply for this job.