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Consultant-Quality Assurance

1 month ago

Greenfield, United States Elanco Tiergesundheit AG Full time
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Consultant-Quality Assurance

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locations

Greenfield, IN

Greenfield, IN

time type

Full time

posted on

Posted Yesterday

job requisition id

R

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
Making animals' lives better makes life better- join our team today

Your role:
Quality Assurance


This position is accountable for QC/QA oversight and lifecycle management of assigned contract manufacturing (CM's) and suppliers ensuring that Elanco products meet all regulatory and internal requirements.

This role will act as QC SME and will actively collaborate with quality, regulatory, technical services, operations, and supply chain counterparts to maintain the routine of quality document reviews/approvals, batch release support and tech agenda as needed.


Including, but not limited to, authoring, reviewing and/or approving method transfer and method validation protocols and reports for the following technologies: parenteral, oral solid dose, non-sterile liquid & Nutritional Health, premix, API, and EPA/parasiticide products.


Your Responsibilities:
Assure the robust selection and on-boarding of CMO's / Suppliers that perform testing for Elanco are in compliance with regulatory cGMP requirements and the Elanco Quality Manual / Directives
Manage and support the resolution of issues at CMOs/Suppliers, escalate issues appropriately and timely drive corresponding continuous improvement initiatives.
Support and guide internal functions within Elanco and external partners (e.g. interpretation of

regulations/standards,

inspection readiness, etc.)
Manage contract laboratories that perform testing of commercial products

Review and approve OOS, OOT Investigations, and deviations related to QC activities and perform assessments and visits of contract manufacturers and laboratories.

Assist with preparation and review of submission documents
Provide support for new product

launches/acquisitions

to ensure compliant systems and procedures are in place to manage new products
Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including laboratory validation reports, technical documents, and stability reports

Partner with QC SMEs in the EEM network for continuous processes and procedures improvements and alignment with the respective Quality Control practices.

Collaborate and/or partner with Global QC network, QA/QC and TS/MS SMEs across organization in projects and routine to support multi-countries marketed products.

Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training

Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.


What You Need to Succeed:
(basic qualifications):
Degree in chemistry, biochemistry, engineering, pharmacy, biology

Minimum 8 years demonstrated Quality/technical leadership experience in the pharmaceutical industry, specifically supporting method transfers, method validation, method optimization, compliance remediation activity.

API chemistry experience highly preferred
Experience performing oversight and audits of laboratories
Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management

Strong knowledge of mathematics, data analysis, and statistical methods and current working knowledge, including audit/inspections, of the regulatory environment – FDA; EU, etc.

Demonstrated understanding of scientific and technical data, problem solving, quality risk management, project management and decision-making skills
Effective influencing & collaboration abilities – working across various cultures, languages, work styles and levels within a global organization
Excellent communication and listening skills, with strong observational, analytical, and problem-solving skills.
What will give you a competitive edge (preferred qualifications):

  • Master's degree preferred in chemistry, biochemistry or chemical engineering
Continuous Improvement (Operational Excellence / Lean) leadership – can comfortably quantify & articulate the impact of projects and their impact to an organization

Expected Travel:
Up to 20%
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:
Relocation packages
Two-week shutdowns (mid-summer and year-end) in the US (in addition to PTO)
10-week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401K matching
Dependent and childcare support
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

About Us

Elanco Animal Health Incorporated (

NYSE:
ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole.

With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities.

At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework – all to advance the health of animals, people and the planet.

Learn more at .

#J-18808-Ljbffr

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