QC Chemist

Job Listing No: 9740000

QC Chemist

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:The QC Chemist serves as a technical resource for the Chemistry laboratory.? The QC Chemist will own the Chemistry methods and equipment from a technical perspective in regards to the execution of the laboratory methods.? The Chemist will be knowledgeable of laboratory operations and provide guidance to technicians based on compliance requirements.? The Chemist will perform required root cause analysis for analytical investigations to ensure that appropriate actions are executed to prevent recurrence.? In addition, the Chemist will work to improve lab operations via continuous improvement projects.?Assists QC Manager with updates of quality systems for analytical testing of raw materials, bulk powder, and finished productProvides technical support for continuous improvement in operations by involvement in SOPs and change control systemsAssists in the continued training and development of all team members in the areas of safety, cGMP compliance, and on-the-job requirementsEffectively communicates with plant personnel, contract testing laboratories, vendors, and QC team membersDevelops new methods/techniques, and improves existing test methods, as neededReviews and approves SOPs, analytical data, and corrective action reportsAssesses any non-conformance/out-of-specification (OOS) results, determines impact on product, and ensures timely resolution or corrective actionPrepares systems and method trends utilizing statistical process controlParticipates in quality audits and audit responses as neededAssists in coordinating responses to audit observationsIdentifies and coordinates qualification of contract testing laboratories as neededPerforms many of the following procedures:? HPLC (reversed-phase, size-exclusion), SDS-PAGE, ELISA, Karl Fischer titrimetry, In-vitro dissolution, Particle size analysis, UV/Vis spectrophotometry, Atomic absorption spectrophotometryFollows appropriate protocols, SOPs, compendial and analytical methods, and stability protocols for sampling and testing active pharmaceutical ingredient and finished product.Maintains appropriate equipment, records, files, and logs according to SOPs and applicable regulatory requirements.Performs basic diagnostic and troubleshooting procedures for test methods and instrumentation.Assists in the maintenance of laboratory requirements, including reagents and suppliesReviews trending of data and helps to manage sample backlogs.Assists with training of Chemistry personnel as required.Able to handle change productively and handle other tasks as assignedBasic Qualifications ?? ?Bachelor's Degree in Biochemistry, Chemistry, or a related science degreeTwo years of bench experience required.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 ?? ?Intimate familiarity with instrumental analysis of protein samples (i.e., HPLC, IVD, SDS-PAGE, viscosity, particle size)Computer skills (Excel, Word, SmartLab, Empower, LIMS).Method and/or equipment validation experienceExperience in protein manufacture, highly recommended.Understanding of cGMP and other regulatory standards for Finished Pharmaceuticals and Active Pharmaceutical Ingredient (API)Preference will be given to individuals with strong pharmaceutical industry experience.Excellent communication and organization skillsStrong interpersonal and team building skills; desire and ability to work in a team environmentMust be able to follow detailed instructions as well as work in safe and responsible mannerMust be able to function responsibly and independentlyAdditional Information ?? ?Must handle chemicals and biohazardous materialsLilly 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 : 28-Feb-2017

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