Senior QA Specialist Sangart
THIS JOB HAS EXPIRED Description of Duties
Comply with all company policies and procedures, current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements.
Support manufacturing and laboratory processes, investigations, change controls and quality improvement efforts.
Perform routine quality audits of manufacturing and laboratory environments, equipment and procedures.
Collaborate cross-functionally to solve issues and implement quality improvements impacting manufacturing and laboratory operations.
Perform assigned tasks and work to achieve company goals and department objectives.
Collaborate with management to establish and meet targets and timelines.
Identify, design and implement process and system improvements.
Apply advanced quality system theory and detailed knowledge of U.S. and European regulatory requirements to make sound quality decisions.
Represent Quality Assurance (QA) on cross-functional teams.
Monitor and proactively manage trends in quality performance using advanced database tools and statistics to identify and implement continuous improvements within the quality systems.
Review and approve complex quality system data and documentation.
Write and revise standard operating procedures (SOP) and related documents.
Investigate and resolve quality system discrepancies with minimal direction.
Recognize quality system deficiencies and implement improvements.
Support quality system audits, as required.
Manage tracking and reporting databases and the associated metrics.
Provide mentoring to other QA staff members, as required.
Develop and deliver quality and compliance related training presentations, as required.
Minimum Job Qualifications
Bachelor?s Degree in science, engineering or related field from an accredited college or university and at least six (6) years related experience, preferably in a quality assurance environment.
Some supervisory and/or laboratory experience is preferred.
Solid investigation, root cause analysis and problem solving skills.
Ability to develop plans for implementation of corrective and preventive action measures.
Strong organizational, time management and communication skills.
Ability to negotiate through controversial issues with a balanced and diplomatic approach.
Ability to handle multiple tasks simultaneously.
Proficient with standard office software programs.
||6175 Lusk Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED