FULL_TIME

FEED

OTHER

Perform QA review/approval of controlled documents including, but not limited to, solution records, batch records, logbooks, autoclave cycles with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls. This position coordinates and conducts activities of the Quality Assurance Department regarding manufacturing floor support and has specific responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager.

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.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: Quality Assurance Associate – Manufacturing FloorThis position coordinates and conducts activities of the Quality Assurance Department regarding manufacturing floor support and has specific responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager. This position plays a key role in day-to-day operations and works very closely with the Manufacturing and Process Teams.Your Responsibilities:<ul><li>Actively interact with Manufacturing and champion compliance through leadership and example in daily processes. Provide quality floor support, including observing daily active processes for: statuses, issues, concerns, and issuance of cell banks. Act as first responder for manufacturing activities and represent QA on cross-functional process teams.</li><li>Identify, investigate, and resolve complex technical issues using problem-solving skills. Participate in investigation teams, determine next steps and assist in the proper close out and follow up actions. Make decisions independently and notify management of actions taken.</li><li>Perform QA review/approval of controlled documents including, but not limited to, solution records, batch records, logbooks, autoclave cycles with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.</li><li>Review change management documentation, deviations, investigations and CAPA records for completion. Write new documents and revise existing QA documents as needed.</li><li>Participate and manage QA projects as needed with minimal supervision. Receive overall project direction from management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.</li></ul>What You Need to Succeed (Minimum Qualifications):<ul><li>BA/BS (or Master's) in any Life Science discipline preferred, and/or 3 years’ experience in regulated industry (USDA, FDA, ISO etc).</li><li>Must have direct experience with Quality Assurance within regulated industry (USDA, FDA, ISO, etc.)</li><li>Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations.</li><li>Must be able to work in controlled / clean room environments requiring gowning qualifications.</li></ul>What Will Give You the Competitive Edge (Preferred Qualifications):<ul><li>Familiarity with basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.</li><li>Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.</li><li>Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.</li><li>Demonstrated experience making sound independent decisions.</li></ul>Additional Information<ul><li>Location: Elwood, KS Manufacturing Site</li><li>Must be able to work in controlled / clean room environments requiring gowning qualifications.</li></ul>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:<ul><li>Multiple relocation packages</li><li>Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)</li><li>8-week parental leave</li><li>9 Employee Resource Groups</li><li>Annual bonus offering</li><li>Up to 6% 401K matching</li></ul>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<img alt=" " height="1" src="https://ars2.equest.com/?response_id=791c1f917687a07691cc7db7f1f797db&view" width="1"/>

Elanco

Quality Assurance Associate – Manufacturing Floor

Animal Care

Autoclave

Biology

Cleanroom

Cross-Functional

Detail Oriented

Disease Prevention and Control

Diversity

Document Management

Documentation

Drug Manufacturing

FDA (Food and Drug Administration)

GMP (Good Manufacturing Practices)

ISO (International Organization for Standardization)

Interpersonal Skills

Leadership

Manufacturing

Manufacturing Requirements

Manufacturing/Industrial Processes

Multitasking

Problem Solving Skills

Project/Program Management

Quality Assurance

Quality Management

Risk

Service Delivery

Statistics

Technical Writing

Time Management

United States Department of Agriculture (USDA)

equestftpin

The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.

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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.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: Technical Services Manufacturing ScientistThe Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial downstream operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects.Your Responsibilities:<ul><li>Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events.</li><li>Act as the Process Teams product and process subject matter expert for purification processes which may include chromatography, tangential flow filtration, and centrifugation.</li><li>Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements.</li><li>Develop / execute projects to address process performance issues and deliver improvement opportunities.</li><li>Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, process recipes, risk assessments, investigations, technical studies, protocols, and reports.</li></ul>What You Need to Succeed (minimum qualifications):<ul><li>Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline.</li><li>Experience: Experience in the Biotech / Pharmaceutical industry.</li><li>Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills.</li></ul>What will give you a competitive edge (preferred qualifications):<ul><li>MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline.</li><li>Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes.</li><li>Experience in tech transfer, scale up, and validation of biopharmaceutical processes.</li><li>Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools.</li><li>Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.</li></ul>Additional Information:<ul><li>Location: Elwood, Kansas.</li><li>Day shift position. Weekend work on a rotation to provide process support to ongoing operations.</li></ul>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:<ul><li>Multiple relocation packages for eligible roles</li><li>Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)</li><li>8-week parental leave</li><li>9 Employee Resource Groups</li><li>Annual bonus offering</li><li>Up to 6% 401K matching</li></ul>#LI_HLElanco 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 statusElanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our <a href="https://assets-us-01.kc-usercontent.com/4b590e03-b18a-00d2-ed1a-0ad79db125c5/96361b9e-3b96-484f-adce-f598d5be5024/Elanco%20Workforce%20Privacy%20Notice.pdf" rel="nofollow">Elanco Workforce Privacy Notice.</a><img alt=" " height="1" src="https://ars2.equest.com/?response_id=46e83873c858677220d2c41b64bd265e&view" width="1"/>

Summer Manufacturing Jobs in Saint Joseph, MO

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Summer Manufacturing Jobs in Saint Joseph, MO

Quality Assurance Associate – Manufacturing Floor Elanco

Technical Services Manufacturing Scientist (Day Shift) Elanco

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