Quality Assurance Specialist I
Location : Location
US-PA-Denver
ID
2023-4365
Category
Operations
Type
Full Time - Permanent
Overview
Hiring for a Quality Assurance Specialist.
Responsibilities
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
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 Pennsylvania site and occasionally travel to Alice, Texas
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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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.
