Envigo provides the broadest range of research models and related services to the pharmaceutical and biotechnology industries, government, academia, and other life science organizations. We pride ourselves on recruiting the best - professional, forward thinking, enthusiastic and highly motivated people who are passionate about what we do and believe in what we stand for…making a difference in people’s lives. We are evolving to become the best company to work with and to work for. Come and join us as a Quality Assurance Regional Manager at our Indianapolis, IN - we have an exciting future ahead!
Is this you?
Perform Quality Assurance Manager responsibilities as assigned in order to effectively support the implementation of the Quality Management System. Provide quality oversight for customer complaint management, Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA) management, and documentation. Manage processes as customer and internal audit program, deviation management, change control, electronic quality management systems, quality training, and data collection. The Manager is required to support the Indianapolis functions in achieving compliance to quality and animal health standards, company policies and procedures, as well as all applicable regulatory requirements.
Is this you?
We are seeking a Veterinarian to join our dynamic team! This position works as part of our Clinical Services team in Alice, TX. This role will focus on providing veterinary health care for laboratory animals, advice regarding the care and maintenance of laboratory animals, and training for technicians. This responsibility extends to promoting animal well-being at all times and during all phases of the animal's life as well as the compliance monitoring, quality management and safety of the animal models. The person in this role will need to be an excellent communicator, proactive problem-solver and a have excellent follow-through. We are seeking someone that shows attention to detail, has excellent time management skills, demonstrates an effective use of time and resources, has a teamwork mentality and positive attitude.
On a typical day, the Quality Assurance Regional Manager will contribute to the Envigo tam by:
Lead and participate in project teams to implement Quality Management Systems including, but not limited to, implementation of Deviation Management process, Change Control, Document Control and Change Management related procedures
Lead and participate in Lean, Six-Sigma Continuous Improvement projects
Manage programs to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and ISO 9001
Review and approve changes to quality systems documentation
Review and approve complaint investigations and perform statistical analysis to identify and communicate complaint trends
Assess deviations and non-conformances with regards to level of risk to product quality
Apply rigorous problem solving methodology, including Pareto and RCA, to situations where data suggest process is not operating effectively or variability exceeds expectations
Review and approve RCA investigations and corrective and preventive actions
Execute and support the audit program: customer audits, supplier audits, internal audits and unannounced regulatory audits
Perform compliance audits against Standard Operating Procedures (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
Collaboratively work with Operations and other functional departments to address audit findings by established deadlines
Collaborate cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
Conduct quality training for new hires as required
Track and trend performance of quality systems and prepare and present status reports for key performance indicators to management
To be successful in this role, this position requires that the Quality Assurance Regional Manager brings:
S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance related area required
Experience with Quality systems and TrackWise® preferred
Lean/Six Sigma Quality related certification preferred
Auditing experience preferred
Experience with performing Root Cause Analysis and Change Control
Excellent computer skills including Word, Excel, Power Point and Visio
Excellent written and verbal communication skills
Excellent organizational skills, analytical abilities, and ability to multi-task
Ability to work collaboratively in a teamwork environment
Occasional domestic travel required
Envigo offers benefits including:
Generous paid time off
Medical, dental and vision insurance
Health savings account
Flexible spending account
Envigo is an EOE, including disability/vets
Envigo provides the broadest range of research models and related services to the pharmaceutical and biotechnology industries, government, academia and other life science organizations. As the largest organization that is solely dedicated to providing research models and related products and services, we are committed to helping researchers realize the full potential of their critical R&D projects as we fulfill our mission to work together to build a healthier and safer world.