Welcome page Returning Candidate? Log back in! Regional Quality Assurance Manager Location : Location US-IN-Indianapolis ID 2024-4757 Category Operations Type Full Time - Permanent Overview

The Regional Manager, Quality Assurance is responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System at the Indianapolis, IN sites.  The manager will provide quality oversight for customer complaint management, root cause analysis (RCA), corrective and preventive action (CAPA) management, and documentation.  The manager will oversee processes, such as the external and internal audit program, deviation management, change control, electronic quality management systems, quality training, and data collection.  The manager is required to support operations in achieving compliance to quality and animal health standards, company policies and procedures, as well as all applicable regulatory requirements.  The Regional Manager is expected to work on site daily at the Indianapolis, IN sites.

Responsibilities Managing programs to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and DEAPreparing and revising documents that support regulatory and statutory requirementsApplying rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectationsTracking and trending performance of quality systems (i.e., customer complaints) and preparing and presenting status reports for key performance indicators to management.Facilitating root cause analysis on significant customer complaints and/or complaint trendsAssess nonconformance reports with regards to the level of risk to product qualityAnalyse trend data to identify key areas of opportunities that impact product qualityFacilitating and reviewing customer correspondence associated with complaintsReviewing and approving complaint investigations and associated RCAs and CAPAsLeading and participating in Continuous Improvement projectsParticipating in the Document Control processReviewing and approving changes to controlled documentation (policies, procedures, etc.)Leading and participating in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related proceduresLeading and participating in customer, supplier, internal and regulatory auditsPerforming compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practicesCollaboratively working with Operations and other functional departments to address audit findings by established deadlinesCollaborating cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveysConducting training for new hires as requiredPromoting and complying with Envigo’s quality assurance proceduresPromoting and complying with Envigo’s health and safety proceduresFulfilling any other assigned duties that may be required by EnvigoManaging direct reportsPerform other duties as assigned Qualifications B.S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance-related area requiredExperience with Quality Management System softwareExcellent Excel skills and/or other data analysis tools to create and analyse data (pivot tables, graphs)Auditing experienceExperience with performing Root Cause Analysis and Change ControlExcellent computer skills including Word, Excel, Power Point and VisioExcellent written and verbal communication skillsExcellent organizational skills, analytical abilities, and ability to multi-taskAbility to work collaboratively in a teamwork environmentAbility to be a self-starter and work independentlyFluent in English, spoken and in writingExcellent interpersonal and customer service skills; builds rapport to influence message, acceptance and understandingExcellent organizational skills and attention to detailActively seeks opportunity to develop own skills and knowledgeGives practical support and assistance to enable individuals to get the job doneDiscusses process improvement opportunities within own department and across other areasDemonstrates effective use of time and resourcesRoutinely meets agreed deadlinesM-F onsite required and need to be available for emergency callsWill be required to enter barriers with biosecurity

Preferred Skills/Abilities:

Experience in the life sciences related industryExperience working around laboratory animal modelsExperience in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)Certified Quality Auditor (CQA)Lean Six Sigma Quality-related certificationAALAS CertificationExperience with JD Edwards

 

 

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience.  The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level.

 

Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity.  Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world.  There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen.  Join us in embracing research and science to impact the health and well-being of people all over the world.

 

Inotiv has been named a 2023 Top Workplace!

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

 

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

 

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