Quality Systems And Compliance Specialist I

Fremont  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Position Summary:
Conducts internal audits for compliance and investigate customer complaints in order to establish root cause. Generate changes to Standard Operating Procedures take Corrective and Preventative Action. Ensure compliance to required cGMP and ISO requirements.

Key Responsibilities:
  • Responsible for coordinating and conducting the following investigations: CAPAs, NCARs, complaints, and internal audits for compliance to Standard Operating Procedures.
  • Prepares documentation of investigation results, and takes corrective action to prevent reoccurrence of on-going or identified problems.
  • Compiles reports of failure investigations and complaint trends while maintaining various quality system logs and records.
  • Revises and maintains standard operating procedures.
  • Gathers data in support of Management review meetings.
  • Ensures conformance to in-house specifications and cGMP/ISO standards.


Minimum Requirements/Qualifications:
  • 0 - 2 years of work experience in Quality Systems within a regulated environment
  • Bachelor's Degree in a Scientific Discipline
  • Laboratory skills including safety, bio-hazardous, and blood borne pathogen material handling
  • Understanding of cGMP and ISO requirements including previous experience with CAPA, Variance, and NCAR closures including root cause analysis
  • Ability to analyze statistical data, interpret results, and process proposed document changes and validations
  • Excellent communication and interpersonal skills with the ability to interact with all levels of the organization and negotiate others


Non-Negotiable Hiring Criteria:
  • Strong analytical and problem solving skills with attention to details
  • Computer skills including MS Office, flowcharting, artwork (Photoshop, Adobe, or others), file management and statistical software


To find out more about Real please visit www.realstaffing.com
Start date
08/2013
From
Real Staffing
Published at
09.08.2013
Project ID:
580130
Contract type
Freelance
To apply to this project you must log in.
Register