Quality Assurance Specialist
Major Duties and Responsibilities :
The Quality Assurance Specialist assists in the development, implementation and evaluation of Cardiocore’s Quality Assurance Program. The QA Specialist authors and revises standard operating procedures, audits the completeness, effectiveness, regulatory compliance, and consistency of all SOPs and ensures that processes are adequate and efficient. Works with Cardiocore staff to correct non-compliance and recommends process changes to meet quality objectives and ensure long-term solutions, reviews audit observations, responds to audit reports, and leads all Corrective Action/Preventive Action activities. Performs internal and vendor audits
Requirements/Qualifications:
- Life sciences or pharmaceutical background strongly preferred
- Proven ability to organize, write, and manage standard operating procedures
- Understanding of 21 CFR Part 11 and general understanding of FDA regulatory requirements including GCP/GXP
- Must be able to communicate effectively and interact easily and diplomatically with all levels of staff and auditors
Education:
- Minimum four year degree, or equivalent work experience
Experience:
- Audit and audit response experience
- Experience with CAPA
Special Skills/Abilities:
- Create new SOPs and revise existing SOPs
- Ensure that SOP procedures are followed
- Lead the development and execution of policies, standard operating procedures, and processes.
- Responsible for corrective action/preventive action tasks.
- Facilitate and coordinate the regulatory inspection/audit.
- Interface with client auditors and serve as the primary contact for all audits of the company quality system.
- Review observations, respond to audit reports, and manage all Corrective Action/Preventive Action activities.
- Perform vendor audits