Quality Assurance Specialist Jr

Depends on Experience

Contract: Independent, Corp-To-Corp, W2, 12 null

  • No Travel Required

Skills

preventative maintenancecGMPFDA

Job Description

Role : Quality Assurance Specialist Jr

Work Location : Franksville WI

 

Summary

  • This position supports a wide array of activities related to: Nonconformance Records (NCR), Corrective and Preventive Action (CAPA), Change Control, Product Surveillance, Design Control, New Markets and Risk Management.  Support the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated.  Provide direct support to Quality personnel regarding operation of the department and Quality System.  Provide support to other departmental activities as directed.

Experience

Professional experience

  • GLP/GMP experience preferred
  •  Medical Device experience preferred

Skills

Knowledge, skills and abilities (incl. languages)

  • Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines
  • Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, and/or Validation.
  • Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information
  • Management Systems (LIMS) and Quality Management software is highly preferred.
  • Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.

Knowledge or methods

  • Proficiency with all equipment in the lab, as well as equipment preventative maintenance and method/process troubleshooting.  
  • Familiarity with general laboratory and incoming supply inspection testing.

Personal skills

  • Computer skills including those associated with the word processing, spread sheet programs, databases and statistical analysis. 
  • Ability to prepare testing protocols and reports, operating documents and procedures. 
  • Ability to work with little or no supervision and make effective decisions. 

Some clean room work may be required; no make-up or excessive amounts of jewelry allowed.  Lifting of light to moderately heavy (less than 25 pounds) objects.  Manual Dexterity.

 

Schedule :

1st Shift Monday to Friday