Sr. Quality Assurance and Regulatory Affairs Specialist
Posted on: November 22, 2021
If you are a Sr. Quality Assurance and Regulatory Affairs
Specialist with experience, please read on!
Top Reasons to Work with Us
- Competitive pay and excellent benefits
- Supportive management and team
- Amazing opportunities for growth
- Gain diversified experience
What You Will Be Doing
- Support the development, establishment, and management of a
comprehensive QMS under GCP, GLP and GMP requirements
- Ensures the ongoing compliance with lab regulatory agencies
(FDA, CAP/CLIA, and other regulatory agencies)
- Knowledge of global requirements for medical device and
- Monitors and analyzes trends in Laboratory performance to test
performance, turnaround time, customer service and other
established lab KPI system and process audits, improving process
flow and effectiveness
- Developing and reviewing Laboratory policies and
- Maintains a safe environment for Laboratory staff and comply
with governmental and institutional regulatory policies.
- Provides oversight for inspection activities. Serves as liaison
for activities involving regulatory (i.e., government) bodies and
internal management safety committees, root cause analyses.
- Lead or coordinate external audits of clinical investigator
sites, vendors and service providers
- Report and address nonconformities, performing causal analysis
- Foster an environment of continuous improvement, addressing
systemic gaps in our GCP QMS.
- Lead and/or assist with the preparation, hosting, and closure
of GXP regulatory agency inspections.
- Develop, manage and monitor GCP and GLP documentation
What You Need for this Position
- Quality Assurance
- Regulatory Affairs
- Laboratory Quality Assurance
- In-Vitro Diagnostics is a plus
- Medical Device or Pharmaceutical experience
So, if you are a Sr. Quality Assurance and Regulatory Affairs
Specialist with experience, please apply today!
Email Your Resume In Word To
Looking forward to receiving your resume through our website and
going over the position with you. Clicking apply is the best way to
apply, but you may also:
- Please do NOT change the email subject line in any way. You
must keep the JobID: linkedin : AT- -- in the email subject line
for your application to be considered.***
Anna Thomas - Principal Recruiter - CyberCoders
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
disability, protected veteran status, or any other characteristic
protected by law.
Your Right to Work - In compliance with federal law, all persons
hired will be required to verify identity and eligibility to work
in the United States and to complete the required employment
eligibility verification document form upon hire.
CyberCoders will consider for Employment in the City of Los Angeles
qualified Applicants with Criminal Histories in a manner consistent
with the requirements of the Los Angeles Fair Chance Initiative for
Hiring (Ban the Box) Ordinance.
Keywords: CyberCoders, Los Angeles , Sr. Quality Assurance and Regulatory Affairs Specialist, Other , Lakewood, California
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