Responsible for performing responsibilities as assigned to effectively support implementation of the Quality Management System. Will provide global quality oversight for customer complaint management and associated root cause analysis (RCA), corrective and preventive action (CAPA) management, and documentation. Required to support the functions in achieving compliance to quality and animal health standards, company policies and procedures, as well as all applicable regulatory requirements. This role will strive to create a positive and mutually beneficial relationship between Inotiv, its employees and its customers, contributing to achieving the growth of Inotiv RMS business.
This is a remote position with occasional travel required.
- Serves as an administrator of Inotiv's Quality Management System software and provides user support, training and mentoring
- Monitors the lifecycle of complaint entry, investigations and CAPAs to closure and collaboratively works with other functional departments to achieve established targets
- Identifies opportunities to improve efficiencies and reduce turn-around times for answering and managing customer complaints.
- Facilitates complaint records with regard to assignment, categorization, and severity
- Prepares customer complaint metrics and KPIs and analyzes trends
- Facilitates root cause analysis on critical customer complaints and/or complaint trends
- Analyzes trend data to identify key areas of opportunities that impact customer quality
- Tracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to management
- Facilitates and reviews customer correspondence associated with complaints
- Provides support for the entry of customer concerns and complaints into the customer complaint management system software
- Reviews and approves complaint investigations and associated RCAs and CAPAs
- Leads and participates in Continuous Improvement projects
- Manages the Document Control team and leads the Document Control process
- Reviews and approves changes to controlled documentation (policies, procedures, etc.)
- Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
- Leads and participates in customer, supplier, internal and regulatory audits
- Performs compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determines proper implementation of documents and work practices
- Collaboratively works with Operations and other functional departments to address audit findings by established deadlines
- Collaborates cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
- Conducts training for new hires as required
- Six Sigma black belt is preferred
- Regular business travel is required
- Performs other duties as assigned
Requirements
- Education:
- Bachelor's degree in relevant field
- Experience :
- 5+ years' experience in Quality Management Systems and leadership
- Or equivalent combination of education and experience
- Skills & Knowledge:
- Proficient with using Microsoft Excel, Word and PowerPoint
- Experience with laboratory animals, especially rodents
- Experience using Laboratory Information Management System
- Working knowledge of business-related processes/procedures terminology and compliance
- Ability to work either independently or as part of a team
- Demonstrable leadership capabilities with the ability to develop and foster a positive and productive team environment
- Constructive and approachable
- An individual who possesses initiative, drive, and flexibility with the ability to meet established timelines
- Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions.
- Understand business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution.
- Excellent verbal and written communication skills; must be able to relate complex concepts in a concise and easy to understand manner with high attention to detail
- Ability to prioritize and handle multiple demands, often under tight time constraints
- An individual capable of operating effectively in a fast paced, dynamic environment
- Adherence to strict quality control and quality assurance principles
- Strong interpersonal/relationship-building skills that establish trust, credibility and respect with a broad range of internal and external stakeholders, including management
- Effectively work with peers, leadership, and stakeholders in a productive collaborative environment.
- Ability to understand and comply with confidentiality and privacy rules and protect company property and confidential information.
- Empathetic, positive attitude with a desire to help our customers reach their goals.
- Certifications (Preferred but not required):
Travel:
- Occasional travel required
*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 for this role is $92,200 - $110,000 and can adjust along with the level of the role to match the person's relevant experience and/or education level.
#LI-JM1 #LI-Remote *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. 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.
|
Inotiv
parental leave, paid time off, 401(k)
Jan 25, 2025