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
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