Location: Greenfield, IN
Company: Elanco
and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being. 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 c GMP 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 backssments 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, shop, biology Minimum 8 years demonstrated Quality/technical leadership experience in the medical 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 c Gx P 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, interactionual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
Quality Assurance (QA) jobs involve ensuring that products, services, or processes meet established standards of quality through systematic activities and measures. These roles typically focus on preventing defects, identifying potential issues, and implementing solutions to maintain quality consistency. Key features of QA positions include rigorous testing, meticulous attention to detail, and a commitment to continuous improvement. QA professionals work across various industries, from software development to manufacturing, to safeguard customer satisfaction and comply with regulatory requirements.
guidelines are being upheld Reports to Site Manager / Site Supervisor Responsibilities Client relationship & Business development Establishing and maintaining relationships with customers and site personnel Daily communications with various stakeholders at the site level Operations Set up and supervise missions Staffing of missions Training and validate inspectors Coordinate changes in missions Isolate, tag and verify nonconforming material Conduct ongoing audits of effectiveness of work being performed Perform visual, mechanical, and functional verifications to ensure compliance to quality standards and specifications Make independent judgments for subjective scenarios.
Work as an inspector
when required Demonstrates commitment to reduce the risk of workplace accidents Must comply with local and company Health & Safety legislation, laws, and policies Organization & management Ensures all site personnel receive corporate communications Partner with Human Resources for performance and attendance issue resolution Act as a liaison between Site Manager and inspectors Ensure all inspector time is entered , monitored and approved Create and maintain a 5S working environment Technical Update daily system entries in company and customer portals Create and maintain customer and company reports Utilize company web portals to record required audits and documentation Troubleshoot and problem
solve with the supplier and customer for issues pertaining to process flow, new criteria, spikes/spills Create electronic work instructions and have the ability to navigate company and customer websites and portals Other Any other duties as assigned Knowledge, skills, abilities Hard Skills Proficiency in English Computer skills Microsoft Office (basic Microsoft Excel proficiency) and Outlook Proficient in the use of various gauges and measuring devices Ability to lift / move 50 lbs.
Values and Attitude Global team spirit Team player Caring for people Open-minded Excellence Reactive Resilient to pressure Rigorous Customer focus Client oriented Reliable & trustworthy Flexible Initiative Autonomous Innovative Daring Work experience 1+ years of work experience in a supervisory role preferred 1+ year in Quality related position preferred Education background High School Diploma or Equivalent About TRIGO Global Quality Solutions Founded in 1997, TRIGO is a multinational company providing operational Quality Management solutions for the manufacturing sector, especially in the automotive and aerospace industries.
With a team of more than ten thousand professionals present in 20+ countries across 4 continents, TRIGO offers a comprehensive portfolio of Quality Assurance services ranging from inspection to expert auditing, consulting and training.
The unrivaled expertise, industrial mindset and extensive global footprint that TRIGO has built up over the last 3 decades has made TRIGO the leading quality solutions provider using the latest innovative and reliable digital systems and standard processes, delivering results in the most demanding industries. TRIGO has recently started to expand its clientele by offering quality services to the medical, chemical and food industries. TRIGO Global Quality Solutions is committed to the core values of equal employment opportunity.
We are committed to treating people fairly, and with respect and dignity. We offer employment opportunities based upon an individual's qualifications and performance, free from discrimination or harassment because of race, ancestry, place of origin, ethnic origin, color, citizenship, creed, interaction, interactionual orientation, age, marital status, family status, and disability. TRIGO Global Quality Solutions appreciates receiving all expression of interest; however, only those candidates invited for an interview will be contacted. Job Posted by Applicant Pro
Ensures daily operational staff follow written policies, procedures, customer requirements, EPA methods, and certification standards. This responsibility also includes review and approval of data generated in the laboratory and laboratory notebooks. Write, review and approve quality policies and procedures including SOPs, Work Instructions, Laboratory Analysis forms (Lab batch records), Quality Assurance Manual.
Train employees on new or changed procedures and maintain proper training records Set up new certification programs to meet individual state requirements Ensure certification requirements are being met; maintain proper records Lead internal and external audits Ensure audit responses
are completed in a timely manner serve as the primary author on all audit responses Manage laboratory investigations for any Out of Specification (OOS) results, customer complaints, provide written investigation reports that include resolution and corrective actions Stays up to date on EPA's PFAS methods (Changing LOQ requirements for the methods) Ability to wear personal protective equipment Performs other related duties as assigned Heritage believes that each employee makes a significant contribution to our success.
That contribution should not be limited by the assigned responsibilities. Therefore, this position description is designed to outline primary duties, qualifications and
job scope, but not limit the incumbent nor the company to just the work identified.
It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of our endeavors. Education/Experience: Bachelors of Science in Chemistry, Biology, Engineering. Minimum of 5 years in an environmental laboratory setting. Minimum of two years in an environmental quality assurance role is required. Experience in a GMP environment required with PFAS analysis a plus. Experience may substitute for education requirements. Knowledge and Abilities: Requires strong organizational, problem solving, oral and written communications, and writing skills.
Knowledge of Quality by Design is a plus. Strong analytical, critical, and creative thinker. Collaborative and team-oriented. Regular and predictable attendance is an essential function of this job. About The Heritage Group The Heritage Group (THG) is a privately held portfolio of companies focused on creating long-term value by building world-class businesses. Under four generations of family ownership, we employ thousands of people around the world, with operations across North America, Europe, and China, in the core industries of Environmental and Remediation, Specialty Chemicals and Fuel Products, and Construction and Materials.
Driven by innovation and research, our in-house R&D team, Heritage Research Group, specializes in helping our diverse set of companies evolve and adapt to a changing marketplace by providing cutting-edge solutions and exploring new opportunities in its state-of-the-art facility. And while acquisitions, partnerships, internal expansion, and startups may be our cornerstone, we're a family company at heart-aiming to build long-term relationships with our customers, vendors, and partners so that we can turn big challenges into even bigger opportunities to make a difference in the world.
The Heritage Group welcomes the diverse backgrounds, experiences, and perspectives of all to work together to accomplish our goals
