Quality Assurance Specialist I

Hiring for a Quality Assurance Specialist.

Providing administrative support with ongoing assessment and monitoring of compliance to ISO9001:2015 standard, AAALAC guidance and Envigo's Quality Management Systems
• Leading and participating in the Document Control process, including preparing and revising documents that support operations in addition to regulatory and statutory requirements
• Applying rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
• Evaluating customer complaints and supporting the completion of associated investigations and customer communication
• Managing nonconformance reports (NCR) including investigations, corrective action, and verification of effectiveness
• Assisting with management of the Change Control
• Participating in project teams to implement elements of the Quality Management Systems and continuous improvement
• Providing support for scheduling, preparation, and execution of Quality and GDP training
• Preparing for and participating in customer, supplier, internal and regulatory audits
• Collaboratively working with Operations and other functional departments to address audit findings by established deadlines
• Collaborating cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
• Promoting and complying with Inotiv's quality assurance procedures
• Promoting and complying with Inotiv's health and safety procedures
• Providing support in other related duties supporting Quality Assurance

Qualifications:

• Knowledge of the principles of quality systems management
• Knowledge of ISO 9001:2015 standard and AAALAC guidance preferred
• BS/BA in life sciences, business, or equivalent preferred
• Fluent in English, spoken and written

Required Skills/Abilities:

• Excellent computer skills (MS Word, Excel, Outlook, PowerPoint, and Visio)
• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Ability to work collaboratively in a teamwork environment
• Ability to be a self-starter and work independently
• Actively seeks opportunities to develop own skills and knowledge
• Discusses process improvement opportunities within own department and across other areas
• Demonstrates effective use of time and resources and routinely meets agreed deadlines
• Ability to work on site daily at the Alice sites and occasionally travel to Denver, Pennsylvania

Preferred Skills/Abilities:

• Previous experience in Quality Assurance and Regulatory field
• Experience in the life sciences-related industry
• Experience working around nonhuman primates
• Lean Six Sigma Quality-related certification

*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 participation with company match, 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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