Quality Assurance Assistant

BioPhase • united states, united states, us • 2m ago

This is a 6 month+ contract located onsite in San Diego, CA

The successful candidate will assure adherence to standard operating procedures, GXP guidelines, and applicable regulations. Candidates must have excellent attention to detail, communication, organizational abilities, and independent problem-solving skills.

Responsibilities:

· Assist with supplier qualification efforts, including sending qualification questionnaires to suppliers and performing initial review of completed questionnaires and supplier documentation

· Route supplier change notifications received to internal business owners for evaluation

· Support material and product retains and archival process, inclusive of clinical drug product reconciliation

· Follow up on GxP audit CAPAs

· Scan, log, and file documents

· Scan, log, and stage documents for offsite storage

· Enter data in Quality’s internal system(s) when processing documents

· Perform other Document Control and Supplier Quality Management related duties as assigned

Qualifications

· High School Diploma or equivalent

· 1+ years of experience working in a Quality Assurance organization in Pharma or Biotech

· Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members

· Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel