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Quality Manager
Ref No.: 19-10713
Location: Swiftwater, Pennsylvania
Sunrise System Inc. is currently looking for Quality Manager in Framingham, MA with one of our top client.
Job Title: Quality Manager
Job Id: 19-10713
Location: Swiftwater, PA 18370
Duration: 5 months
Position Type: Hourly contract Position (W2 only)
 
Summary
  • This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.
  • Requires strong Commissioning and Qualification background. 
Key Accountabilities
  • Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines
  • Review and approve validation related studies for assigned areas.
  • These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
  • Signatory responsibilities for validation/qualification documents within assigned areas.
  • This position, with direction from QV management, is responsible for providing Quality &
  • Compliance oversight to site validation projects related to Drug Substance and/or Drug Product
  • Vaccine manufacturing. Requires strong Commissioning and Qualification background. 
Key Accountabilities
  • Participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines
  • Review and approve validation related studies for assigned areas.
  • These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.
  • Signatory responsibilities for validation/qualification documents within assigned areas. 
Skills
  • Technical Competencies:
  • Working knowledge of cGMPs and regulatory requirements
  • Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to
    validation processes.
  • Knowledge of vaccines/biologics products and associated technologies
  • The ability to work on cross functional project teams
  • Meet/Exceed project timelines/deliverables
  • Experience with Quality Systems including: SAP, Quality eDoc, Lab Ware, Track Wise and MS Office
  • Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for
  • Results, Cooperate Transversally, Commit to Customers, Make Decisions
Education
  • 5+ years' experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment. 
Skills and Experience
  • CGMPS
  • FDA
  • LABWARE
  • Manufacturing Processes
  • MS Office 
Additional Skills
  • Quality Manager
  • Risk Management
  • SAP
  • TRACKWISE
  • GMP
  • Microsoft Office 
Contact
Savitha Divakaran
Direct: (732) 272 0299 | Email: Savitha.D@sunrisesys.com
Or
Satya S
Direct: (732) 272.0262 | Email: Satya@sunrisesys.com