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Posted: Wednesday, June 28, 2017 6:33 AM

Job Description:/h3:
Crown Bioscience San Diego has a Quality Assurance Manager opportunity with responsibility to manage the Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibration maintenance and internal auditing.

Key Duties and Responsibilities:
:Provide focus for the Quality Management System and work closely with all departments and functions to promote processes that ensure consistency, continuous improvement and compliance with quality and business requirements.
:Provide support for Quality Systems and maintain the appropriate level of customer service. Has the ability to write clear, coherent internal business communications / reports. Formally presents results of work.
Prepare, host and respond to findings for external client audits.
:Non Conformance Reports and monitoring reporting performance and trends.
:Problem solve, identification of root cause and implementation / follow up of corrective procedures and preventive actions to ensure timely resolution of such problems.
:Ability to perform internal audits as required according to site and global plans.
:Use auditing as a proactive tool for improvement as well as compliance and challenge existing practice where appropriate.
:Timely completion and follow up through to closure of CAPA actions.
:Measuring and monitoring of performance against agreed KPIs.
:Collate and share information / data across the site as appropriate through reports and follows up on identified improvement opportunities.
:Actively contribute to the success of the overall QA team and the site.
:Actively participate and/or drives EU/Global QMS improvements as required
:Bachelors Degree in a
Scientific/Technical field (i.e. Chemistry, Biology, or Engineering).
:Effective communication skills are required, both written and verbal.
:Problem solving skills are required in situations that are not procedurally managed.
:Analytical ability is required to make competent decisions based on a review of analytical data
:Experience with GLP/ ISO9001 and life sciences industry experience
:Approximately 10:15 travel may be required
Non:Negotiable Hiring Criteria:
:Experience in a Regulated Quality environment
:Audit experience (as Auditor or Auditee)

Company Description:/h3:
Our mission is to help our clients maximize the benefits of targeted therapeutics and increase the success of their clinical trials. We offer fully:integrated solutions for the discovery and application of molecular markers that are predictive of patient response in clinical trials. If you share these values and passions, this is the environment for you.


• Location: San Diego

• Post ID: 28976298 sandiego is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2017