Senior Quality Control Assistant, Biochemistry

Elanco; Elwood (NY); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company dedicated to improving animal health through innovative solutions. As a Senior Assistant in Quality Control, you will play a crucial role in conducting biochemical assays and ensuring compliance with stringent quality standards. Your expertise will contribute to high-value projects that enhance the health of both farm animals and pets. With a commitment to diversity and inclusion, this role offers a collaborative environment where you can grow your skills and make a meaningful impact. If you're passionate about science and making a difference, this opportunity is perfect for you.

Benefits

Two weeklong shutdowns

8-week parental leave

Annual bonus offering

Up to 6% 401K matching

Employee Resource Groups

Qualifications

• 5+ years in a GxP laboratory with strong focus on documentation.
• Experience in method development and validation in a lab environment.

Responsibilities

• Conduct biochemical assays and ensure compliance with cGMP guidelines.
• Prepare and approve QC documentation, including test protocols and reports.

Skills

GMP laboratory experience

Biochemical assays

Attention to detail

Documentation skills

Method development

Education

Bachelor's degree in Biological Sciences

Bachelor's degree in Chemistry

Tools

Analytical software

Laboratory equipment

Job description

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