QA Specialist

Job Title:

QA Specialist

Department:

Quality Assurance

Reports To:

Senior Director, QA/QC

Pay Classification:

Non-Exempt

Position Summary:

Responsible for participating in the management and maintenance of the Quality System and related documents and processes.

Duties & Responsibilities include but are not limited to:
  • Assisting in managing the Document Control System
  • Develop and implement quality related procedures
  • Ensure companywide compliance to FDA and ISO regulations
  • Coordinate Corrective and Preventative Action system
  • Assisting in performing Change Control processes
  • Maintain training records
  • Train QA personnel in related procedures and functions
  • Provide support with compliance (cGMP) audits, customer audits, & vendor audits
  • Assisting with the vendor qualification and evaluation program
  • Manage non-conforming material and dispositions
  • Review batch records for product releases
  • Participate in company committee and / or project meetings
  • Prepare reports for deviations, CAPA’s, and non-conformances
  • Compile and trend quality system data
  • Participate in managing the Internal Audit program
  • Oversee the daily activities of the Quality Assurance Inspectors.
Qualifications Required:
  • BA or BS (in the life sciences preferred)
  • Three to five+ yrs. experience in Quality for an FDA regulated industry preferred
  • Proficient in FDA and ISO regulations.
  • Proficient in MS Word, Excel, Power Point
  • Ability to work and succeed in a cross-functional environment

For immediate consideration, please send a resume to srivera@chembio.com Chembio is an Equal Opportunity Employer.