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Quality Manager
Ref No.: 19-05801
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Quality Manager in Swiftwater, PA with one of our top client.
 
Job Title: Quality Manager
Job Id: 19-05801
Location: Swiftwater, PA 18370
Duration: 8 months
Position Type: Hourly contract Position (W2 only)
 
Duties
  • Represent the site quality organization with expertise in Data Integrity.
  • Maintain currency with U.S. and European regulations related to Data Integrity.
  • Perform Data Integrity risk assessment of manufacturing and laboratory systems.
  • Evaluate proposed and existing manufacturing equipment, instrument systems and laboratory applications for Data Integrity gaps. 
Experience
  • Relevant quality assurance experience (comparable to 10+ years) including expertise in GMP regulations gained from time served in a pharmaceutical, biotechnology and/or medical device industry
  • 5+ years working in a GMP regulated environment
  • 3+ years of experience quality role
  • 3+ years of experience in a computer systems validation
    Or equivalent combination of education, training and experience that provides the knowledge, skills and abilities to perform the duties of the job. 
Required Knowledge, Skills and Abilities
  • Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity
  • Expertise in all aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis and Total Quality Management)
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Education
  • Bachelor's degree (or equivalent) required in a relevant scientific discipline
Required Skills
  • Data Integrity
  • FDA
  • Biotechnology
  • GMP
  • Computer Validation 
Additional Skills
  • Medical Device
  • Pharmaceutical GMP
  • Quality Manager
  • Root Cause Analysis
  • Total Quality Management
  • Laboratory
  • Quality Assurance
  • Risk Assessment 
Contact
Dayanand Barki
Direct: (732)-272-0326 | Email: dayanand.b@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com