Netherlands Job Openings
Inotiv
Manager, Quality Assurance
Horst
FULL TIME
October 7, 2024
- Managing programs to ensure compliance with regulatory and statutory requirements
- Preparing and revising documents that support regulatory and statutory requirements
- Applying rigorous problem-solving methodology to situations where data suggest process is not operating effectively or variability exceeds expectations
- Tracking and trending performance of quality systems (i.e., customer complaints) and preparing and presenting status reports for key performance indicators to management
- Facilitating root cause analysis on significant customer complaints and/or complaint trends
- Assess nonconformance reports with regards to the level of risk to product quality
- Analyse 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, but not limited to, 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 Inotiv’s quality assurance procedures
- Promoting and complying with Inotiv’s health and safety procedures
- Fulfilling any other assigned duties that may be required by Envigo
- Managing direct reports
- Perform other duties as assigned
- 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 analyse data (pivot tables, graphs)
- Auditing experience
- Experience with performing Root Cause Analysis and Change Control
- Excellent computer skills including Word, Excel, Power Point 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
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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