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Company : Optghar
Req/job Title : QA
Job Ref No : 1168
Post Date : 01/09/2018
Country : USA
Job State/Province : Massachusetts
Job City : Bedford
Experience : 2 - 3
OtherSkill : May support the following tasks: Create deviations and OOS report, support root cause analysis and CAPA as requested. Assist in writing and reviewing new and existing SOPs Participate in and support Continuous Improvement Projects Required to wor
Subject : Quality Control Technician
Description :

Job Description 

  • QA/QC Technician performs Quality Control functions independently or under moderate instruction including
  • Inspection and release of raw material
  • Inspection of finished packaged goods
  • Issuing of line clearances in support of manufacturing processes
  • Data entry in SAP
  • Water sampling and buffer preparation. 
  • The successful candidate will follow and adhere to in-house testing procedures and maintain compliance with ISO9001, ISO13485, safety and regulatory requirements as they apply to the laboratory and work areas. 
  • Minor local travel by car is required. In addition, the Intermediate Technician functions as key member of the QC group
Minimum Requirements: 
  • Requires a BS or higher in Chemistry, Biology, Biotech or related fields, with 1-3 years of experience in a Biotech/Pharma/Clinical QC environment. 
  • Compliance knowledge with ISO9001, ISO13485, ICH Q2, GMP/GLP requirements preferred. 
  • Knowledge of Process Excellence, Six Sigma and Lean Manufacturing is a plus. 
  • Must be able to work independently as well as work with a diverse team. 
  • Knowledge of SAP or similar inventory control systems desired. 
  • Familiar with Microsoft Excel and Word. Excellent oral and written communication skills are required to be effective in this role.