Regional Quality Assurance Manager

Company: Envigo ++++
Location: Livermore
Posted on: August 6, 2022

Job Description:

Envigo provides the broadest range of research models and related services to the pharmaceutical and biotechnology industries, government, academia, and other life science organizations. We pride ourselves on recruiting the best - professional, forward thinking, enthusiastic and highly motivated people who are passionate about what we do and believe in what we stand for---making a difference in people's lives. We are evolving to become the best company to work with and to work for. Come and join us as a Quality Assurance Regional Manager at our Livermore, CA - we have an exciting future ahead! Is this you? Perform Quality Assurance Manager responsibilities as assigned in order to effectively support the implementation of the Quality Management System. Provide quality oversight for customer complaint management, Root Cause Analysis (RCA), Corrective Action Preventive Action (CAPA) management, and documentation. Manage processes as customer and internal audit program, deviation management, change control, electronic quality management systems, quality training, and data collection. The Manager is required to support the Indianapolis functions in achieving compliance to quality and animal health standards, company policies and procedures, as well as all applicable regulatory requirements.
On a typical day, the Quality Assurance Regional Manager will contribute to the Envigo tam by:

• Lead and participate in project teams to implement Quality Management Systems including, but not limited to, implementation of Deviation Management process, Change Control, Document Control and Change Management related procedures
• Lead and participate in Lean, Six-Sigma Continuous Improvement projects
• Manage programs to ensure compliance with regulatory and statutory requirements, including AAALAC, IACUC, USDA and ISO 9001
• Review and approve changes to quality systems documentation
• Review and approve complaint investigations and perform statistical analysis to identify and communicate complaint trends
• Assess deviations and non-conformances with regards to level of risk to product quality
• Apply rigorous problem solving methodology, including Pareto and RCA, to situations where data suggest process is not operating effectively or variability exceeds expectations
• Review and approve RCA investigations and corrective and preventive actions
• Execute and support the audit program: customer audits, supplier audits, internal audits and unannounced regulatory audits
• Perform compliance audits against Standard Operating Procedures (SOPs) and Work Instructions (WIs) to determine proper implementation of documents and work practices
• Collaboratively work with Operations and other functional departments to address audit findings by established deadlines
• Collaborate cross-functionally to ensure thorough, accurate and timely responses to customer audits and surveys
• Conduct quality training for new hires as required
• Track and trend performance of quality systems and prepare and present status reports for key performance indicators to managementTo be successful in this role, this position requires that the Quality Assurance Regional Manager brings:
  • B.S./B.A. required in technical degree; 3-5 years of experience working in Quality Assurance related area required
  • Experience with Quality systems and TrackWise - preferred
  • Lean/Six Sigma Quality related certification preferred
  • Auditing experience preferred
  • 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
  • Occasional domestic travel requiredEnvigo offers benefits including:
    • Generous paid time off
    • Paid holidays
    • Medical, dental and vision insurance
    • Health savings account
    • Flexible spending account
    • 401(k)Envigo 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.

Keywords: Envigo ++++, Livermore , Regional Quality Assurance Manager, Executive , Livermore, California