Secondary Loop Representative – QA in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Secondary Loop Representative – QA in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Secondary Loop Representative – QA

Location : Indianapolis, Indiana

Job id: R-33701

 

Job Details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Organization Overview:The mission of Quality Assurance is to provide independent oversight for manufacturing operations to ensure all products and materials meet quality requirements for their intended use and that quality systems are created, monitored and maintained.  The Secondary Loop QA Rep in Parenteral Manufacturing is a key member in a cross-functional team who provides assistance and guidance to Floor Support staff to achieve the reliable and compliant manufacture of parenteral drug product. The Secondary Loop QA Rep position is essential for maintaining GMP compliance and providing support during preparation for Pre-Approval / General Inspections by various regulatory agencies. Key Objectives / Deliverables:Responsible for adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting HSE corporate and site goalsLead, mentor, and coach operations and support personnel on quality mattersEnsure regular presence in operational areas to monitor GMP programs and quality systemsInteract with process teams by representing the Quality function to support improvement and productivity objectives including development and implementation of process improvement, including capital expansions and technical projects.Ability to assess and triage deviations / observations that occur within the local process teamWork with Lilly support groups and external partners to resolve or provide advice on product related issuesParticipate in self-led inspections and provide support during internal / external regulatory inspectionsWork within cross-functional teams in a positive fashion to implement quality objectives and deliver on business plan and site objectives.Lead and/or support project and process improvement initiatives for Plant Process Teams as representative of the Quality functionAuthor, review, or approve documents, including control strategies, investigations, change controls, validations, qualifications, procedures, technical studies, etc. to ensure quality attributes are met and compliance with quality standards.Participate in self-led inspections and provide support during internal / external regulatory inspectionsNetwork with Global Parenteral Network sites as resources and benchmarking sourcesBasic Requirements:Minimum of Bachelor’s Degree required in scientific disciplines of Biochemistry, Protein Chemistry, Biophysical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, or Engineering (or equivalent work experience).Additional Skills/ Preferences:Proficiency with computer systems including Microsoft Office products.Good written and oral communication and interpersonal skills.Knowledge and understanding of manufacturing process and Quality SystemsStrong technical writing skillsAbility to work independently or as part of a team to resolve an issueStrong decision making and problem-solving skillsStrong attention to detailDemonstrated relevant experience in a GMP facilityKnowledge of parenteral manufacturing and aseptic manufacturing practicesProficiency with local computer systems including Veeva, TrackWise, PMX, and SAPAdditional Information:Day Shift, possible off-shift support.This position will be in Indianapolis, but could require some travel, less than 10%, including international.Tasks require entering manufacturing areas which require wearing appropriate PPE.This position is tech ladder approved.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

 

 

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