Quality Assurance Specialist I

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.

• Providing administrative support with ongoing assessment and monitoring of compliance to ISO9001:2015 standard, AAALAC guidance and Envigo’s Quality Management Systems
• Support in the preparation, execution, and follow-up for customer and regulatory audits
• Assisting with the management of Envigo controlled documents (SOPs, Work Instructions, Policies, etc.)
• 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
• Supporting records retention and archiving processes
• Assisting with management of the Change Control process
• Support for scheduling, preparation, and execution of Quality and GDP training
• Performing internal and/or external audits
• Assisting in managing calendars and communications
• 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

Required Skills/Abilities:

• Excellent computer skills (MS Word, Excel, Outlook)

• Excellent verbal and written communication skills
• Excellent interpersonal and customer service skills
• Excellent organizational skills and attention to detail
• Actively seeks opportunities to develop own skills and knowledge
• Demonstrates effective use of time and resources
• Routinely meets agreed deadlines
• Builds rapport to influence message, acceptance and understanding

Preferred Skills/Abilities:

• Previous experience in Quality Assurance and Regulatory field

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, gender, gender identity, sexual orientation, physical or mental 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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