Inotiv

Senior Manager, Quality Assurance

Inotiv

full-time

Posted on:

Location Type: Hybrid

Location: Alice • Texas • United States

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Job Level

Senior

About the role

  • Leads a Quality Assurance team to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and CDC
  • Provides guidance, support, mentoring, and training to direct reports
  • Prepares and revises documents that support regulatory and statutory requirements
  • Applies rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
  • Prepares customer complaint metrics and KPIs, and analyses trends
  • Facilitates root cause analysis on significant customer complaints and/or complaint trends
  • Assesses nonconformance reports with regards to the level of risk to product quality
  • Analyzes trend data to identify key areas of opportunities that impact product quality
  • Tracks and trends performance of quality systems and prepares and presents status reports for key performance indicators to management
  • Facilitates and reviews customer correspondence associated with complaints
  • Reviews and approves complaint investigations and associated RCAs and CAPAs
  • Leads and participates in Continuous Improvement projects
  • Leads and participates in the Document Control process
  • Reviews and approves changes to controlled documentation (policies, procedures, etc.)
  • Leads and participates in project teams to implement Quality Management Systems elements including, but not limited to, Deviation Management, Document Control and Change Management related procedures
  • Leads and participates in customer, supplier, internal and regulatory audits
  • Performs compliance audits against Standard Operating Procedure (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
  • Collaborates cross-functionally to address audit findings by established deadlines
  • Conducts training for new hires as required
  • Promotes and complies with quality assurance procedures
  • Promotes and complies with health and safety procedures
  • Six Sigma Green Belt or higher is required
  • Regular business travel is required.

Requirements

  • 3+ year’s experience in Quality Assurance leadership
  • Proficient with advanced skills using Microsoft Excel, Word and PowerPoint
  • Experience with laboratory animals, especially rodents preferred
  • Working knowledge of business-related processes/procedures terminology and compliance
  • Experience using Laboratory Information Management System preferred
  • Ability to work either independently or as part of a team
  • Demonstrable leadership capabilities with the Ability to develop and foster a positive and productive team environment
  • Constructive and approachable
  • An individual who possesses initiative, drive, and flexibility with the ability to meet established timelines
  • Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions.
  • Understand business needs from multiple points of view and provides suggestions to address current issues while also maintaining a long-term solution.
  • Excellent verbal and written communication skills; must be able to relate complex concepts in a concise and easy to understand manner with high attention to detail
  • Ability to prioritize and handle multiple demands, often under tight time constraints
  • An individual capable of operating effectively in a fast paced, dynamic environment
  • Adherence to strict quality control and quality assurance principles
  • Strong interpersonal/relationship-building skills that establish trust, credibility and respect with a broad range of internal and external stakeholders, including management
  • Effectively work with peers, leadership, and stakeholders in a productive collaborative environment.
  • Strong commercial skills
  • Ability to understand and comply with confidentiality and privacy rules and protect company property and confidential information.
  • Empathetic, positive attitude with a desire to help our customers reach their goals
Benefits
  • health and dental coverage
  • short- and long-term disability
  • paid time off
  • paid parental leave
  • 401K
  • and more!
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality AssuranceRoot Cause AnalysisContinuous ImprovementDeviation ManagementDocument ControlChange ManagementCompliance AuditsKPI AnalysisSix Sigma Green BeltLaboratory Information Management System
Soft Skills
LeadershipProblem-solvingAnalytical thinkingCommunicationInterpersonal skillsTeam collaborationInitiativeFlexibilityAttention to detailTime management
Certifications
Six Sigma Green Belt