For The Candidates

Qa Senior Specialist - Quality Assurance- GMP- Biologics
MD
Type: Full-Time
Category: Quality Assurance
Job ID: 779
Opportunity Description:
( 301 ) Area code                                                                        Maryland/ D.C Area
 
 
 

Senior QA Specialist

 

Applicants must meet the following requirements:

  • Bachelors degree in a related discipline with a minimum of 8 years experience
  • Previous QA experience in a GMP, biotech, manufacturing environment is required with at least 4 years experience leading vendor audits
  • ASQ CQA certification a plus
  • Excellent interpersonal skills
  • Excellent organizational skills and attention to detail
  • Must have good writing skills
  • Must be flexible to work as part of a team or individually on special projects
  • Proficiency with Microsoft Word and Excel is required
  • Must be able to read, analyze and interpret data
  • Must be able to travel up to 50%

The selected candidate will be responsible for:

  • Managing the vendor audit program
  • Performance and scheduling of external audits (vendors/contractor)
  • Monitoring the qualification status of vendors
  • Establishing quality agreements with raw material suppliers
  • Tracking the status of vendor audit responses, quality agreements and notifications
  • Writing vendor audit reports and evaluating vendor audit responses
  •  Determining vendor acceptability
  • Collaborating with the Quality Control department on raw material qualification

Benefits:  Competitive salary and benefits package

 
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