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Senior Quality Assurance Auditing Specialist - "GLP Auditing / 21 CFR Part 58" (Onsite) job in Irvine at Edwards Lifesciences Corp

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Senior Quality Assurance Auditing Specialist - "GLP Auditing / 21 CFR Part 58" (Onsite) at Edwards Lifesciences Corp

Senior Quality Assurance Auditing Specialist - "GLP Auditing / 21 CFR Part 58" (Onsite)

Edwards Lifesciences Corp Irvine, CA Part-Time
The work location for this position will be Irvine, CA and this role is not eligible to be 100% remote.

This Senior Quality Assurance Auditing Specialist will be responsible for conducting internal and external non-clinical audits (in-vitro and in-vivo) on safety and biocompatibility studies to ensure conformance to 21 CFR Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies), ISO standards, and SOPs.

Key Responsibilities:

* Conduct GLP in-life phase and final report audits including complex assessments, to ensure conformance with applicable regulations, standards, and Edwards' policies and procedures
* Evaluate the appropriateness and effectiveness of corrective actions
* Review GLP protocols, surface area calculations based on drawings, and GLP associated SOPs
* Execute process and system/facility audits on an annual basis, establish audit content, allocate time, and schedule meetings
* Assess previous audit findings to establish priorities and strategies
* Provide input and may lead projects, based on understanding of standards and regulations, to business unit and/or corporate quality initiatives including special projects
* Provide training, guidance, and coaching to junior team members
* Assist in generating metrics for overall auditing system and identify continuous improvement opportunities; may also present metrics to all level of the organization
* Perform supplier audits for contract testing laboratories
* Other duties assigned by management

Minimum Required Qualifications (Must Have):

* Bachelor's Degree with 5 years of quality auditing experience; or Master's Degree with 3 years of quality auditing experience
* Medical device and/or pharmaceutical experience
* Experience in auditing against 21 CFR Part 58

Preferred Qualifications (Nice to Have):

* Degree in science or engineering field
* Full knowledge and understanding of 21 CFR Part 58 and ISO 10993-Parts 1-12
* Ability to manage multiple concurrent audits/reviews
* Strict attention to detail
* Ability to manage competing priorities in a fast-paced environment
* Excellent written and verbal communication skills
* Strong problem-solving and critical thinking skills
* Ability to interact professionally with all organizational levels and be a team player
* Ability to interact with senior personnel on significant matters often requiring coordination between departments
* Knowledge in performing biocompatibility test method verification and equipment validation audits
* Proven expertise in MS Office Suite and ability to operate general office machinery
* Ability to travel, as applicable

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Recommended Skills

  • Assessments
  • Attention To Detail
  • Auditing
  • Business Process Improvement
  • Calculations
  • Clinical Works
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Job ID: 2291509739

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