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This role will be a laboratory-based position with the QC Biochemistry group responsible for a wide variety of biochemical assays. This role will rely heavily on an ability to perform regular functions within a GMP environment and perform flawless lab work on high value projects. Regular projects include release and stability testing, assay development, validation, training, technical writing, and regular use of specialized equipment/software.
Conduct routine and non-routine biochemistry-based analysis of raw materials, in-process materials, finished goods, environmental monitoring samples, and stability samples.
Prepare test protocols, validation protocols, special outlines, reports, and additional forms.
Ensure the QC lab is held to cGxP safety, performance, documentation, maintenance, and environmental standards.
Generate, review, and approve data to ensure accuracy and regulatory compliance.
Prepare, compile, and review Certificate of Analyses, OOS/OOT investigations, and deviations during testing.
Validate new testing methods, and revise and qualify previous testing methods as needed.
Be trained on and help train other analysts to perform laboratory procedures and assays.
Be knowledgeable on theory and current best practices regarding analytical assays.
Become an expert on commonly used software and participate in continuing education to stay current.
Prepare and approve QC standard operating procedures.
Support equipment validation, calibration, and maintenance.
Serve as a SME between QC and other departments, vendors, or contractors.
Supply, write, or review quality control data in regulatory submissions.
Participate in internal assessments and audits as required.
Research and recommend new technologies, methods, instruments, reagents, and other practices to improve the QC department.
Occasionally present data, practices, or other useful materials to company personnel.
Assist other departments at the discretion of the QC Supervisor.
Work closely with a diverse group of peers to meet critical timelines and meet team standards.
Basic Minimum Requirements
Bachelor’s degree in Biological Sciences, Chemistry, or a comparable field with 5 years experience in a GxP laboratory, or Master's or Doctorate with 2 years experience in a GxP laboratory.
Excellent verbal, written, and interpersonal communication skills.
Excellent computer literacy, with the ability to learn new specialized software efficiently. Preference will be given to candidates who currently use similar specialized software to what is currently being used.
Strong attention to detail is needed with a focus on laboratory practice and documentation skills.
High integrity is mandatory as data integrity is the foundation of our department.
Experience in a commercial lab environment dealing with the manufacture of USDA or FDA regulated products.
Experience related to method/equipment validation.
Experience in protein or other bio-macromolecular testing. Technical skills in biochemistry, cell biology, immunology, or microbiology.
Knowledge of VICH, cGMP, VSMs, CFRs, USP and any other regulations directly impacting the business practices of the animal health industry.
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