Senior Quality Control Assistant, Biochemistry (Biotech)
At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better – join our team today!
Your Role: Senior Assistant - Quality Control, Biochemistry
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.
Your Responsibilities
Conducts a range of biochemical assays, encompassing both routine and non-routine testing, on various sample types including raw materials, in-process materials, finished goods, environmental monitoring samples, and stability samples. This includes method development, execution, and troubleshooting.
Prepares, reviews, and approves a variety of essential QC documentation, including test protocols, validation protocols, special outlines, reports, Certificates of Analysis (CoAs), out-of-specification/out-of-trend (OOS/OOT) investigation reports, and deviation reports.
Ensures the QC laboratory operates in full compliance with current Good Manufacturing Practices (cGxP) guidelines, encompassing laboratory safety, performance standards, meticulous documentation practices, regular equipment maintenance, and adherence to environmental regulations.
Generates, reviews, and approves analytical data to ensure accuracy, completeness, and regulatory compliance. Investigates and documents any OOS/OOT results and deviations encountered during testing. Validates new and revised testing methods and qualifies existing methodologies as needed.
Serves as a subject matter expert (SME) and liaison between the QC department and other internal departments, external vendors, and contractors. Provides training to other analysts on laboratory procedures and assays, and stays current with the latest analytical techniques and best practices through continuing education and software proficiency. Participates in internal assessments and audits as required.
What You Need to Succeed (minimum qualifications):
Bachelor's degree in Biological Sciences, Chemistry, or a comparable field
At least 5 years' experience in a GxP laboratory. Preference will be towards a candidate working in manufacturing support. Formal education will be considered in lieu of less experience
Strong attention to detail is needed with a focus on laboratory practice and documentation skills.
What will give you a competitive edge (preferred qualifications):
Preference will be towards a candidate working in manufacturing support.
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.
Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
Elanco Benefits and Perks:
We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
8-week parental leave
9 Employee Resource Groups
Annual bonus offering
Up to 6% 401K matching
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
