Quality Assurance Manager

2 days ago

Indianapolis, Indiana, United States Inotiv Full time
Job Summary:

The Regional Quality Oversight Specialist will be responsible for ensuring compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA, and DEA. This role will involve preparing and revising documents that support regulatory and statutory requirements, applying rigorous problem-solving methodologies to situations where data suggests process is not operating effectively, and tracking and trending performance of quality systems.

Key Responsibilities:

Managing programs to ensure compliance with regulatory and statutory requirements
Preparing and revising documents that support regulatory and statutory requirements
Applying rigorous problem-solving methodologies to situations where data suggests process is not operating effectively
Tracking and trending performance of quality systems
Facilitating root cause analysis on significant customer complaints and/or complaint trends
Assessing nonconformance reports with regards to the level of risk to product quality
Analyzing trend data to identify key areas of opportunities that impact product quality
Facilitating and reviewing customer correspondence associated with complaints
Reviewing and approving complaint investigations and associated RCAs and CAPAs
Leading and participating in Continuous Improvement projects
Participating in the Document Control process
Reviewing and approving changes to controlled documentation (policies, procedures, etc.)
Leading and participating in project teams to implement Quality Management Systems elements, including Deviation Management, Document Control, and Change Management related procedures
Leading and participating in customer, supplier, internal, and regulatory audits
Performing compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
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
Conducting training for new hires as required
Promoting and complying with Envigos quality assurance procedures
Promoting and complying with Envigos health and safety procedures
Fulfilling any other assigned duties that may be required by Envigo
Managing direct reports

Requirements:

B.S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance-related area required
Experience with Quality Management System software
Excellent Excel skills and/or other data analysis tools to create and analyze data (pivot tables, graphs)
Auditing experience
Experience with performing Root Cause Analysis and Change Control
Excellent computer skills, including Word, Excel, PowerPoint, 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
Ability to be a self-starter and work independently
Fluent in English, spoken and in writing
Excellent interpersonal and customer service skills; builds rapport to influence message, acceptance, and understanding
Excellent organizational skills and attention to detail
Actively seeks opportunity to develop own skills and knowledge
Gives practical support and assistance to enable individuals to get the job done
Discusses process improvement opportunities within own department and across other areas
Demonstrates effective use of time and resources
Routinely meets agreed deadlines
M-F onsite required and need to be available for emergency calls
Will be required to enter barriers with biosecurity

Preferred Skills/Abilities:

Experience in the life sciences-related industry
Experience working around laboratory animal models
Experience in Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)
Certified Quality Auditor (CQA)
Lean Six Sigma Quality-related certification
AALAS Certification
Experience with JD Edwards

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