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Quality Inspector in Cambridge,Ma
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QC Associate

Integrated Resources, Inc Andover Contractor
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Position:  QC Associate
Duration: 12 months+
Location:  Andover - MA
 
Job Description:
  • 2-4 years of experience with word, excel, MS office, etc.
  • Project management skills
  • writing skills
  • Multitask, cover timelines, meet timelines, etc.
  • work with others
  • Associates or BA
  • collaborate with other team
  • validate new instruments, writing protocols, data integrity, change controls
•         Looking for an individual to fill a QC Associate role that will be responsible for completing Data Integrity remediation activities, performing instrument periodic reviews, assisting with instrument validation, authoring/revising SOP’s and writing investigations.
•         As required, the QC Associate will also be responsible for review of microbiological laboratory data generated in support of commercial and clinical manufacturing.
•         The candidate must be able to effectively manage multiple projects simultaneously. Project work will require the candidate to work with people from multiple departments.
•         Potential investigation areas include: protocol deviations, cGMP testing deviations, invalid or questionable result investigations, instrument calibration Out-of-Tolerance reports, and environmental monitoring excursions.
•         In addition to performing project work, the individual will be responsible for reviewing cGMP testing data generated by the QC Microbiology testing group for completeness and accuracy.
•         Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals.  
 
Major Role Responsibilities:
  • Understands validation concepts in order to produce documentation for validated systems
  • Provides evidence of compliance with legal, business and regulatory requirements
  • Translates highly technical software functions/features into process driven user friendly materials to support implementation and training of applications
  • Liaises with clients or developers to gather information; and Organizes, synthesizes medical and business literature, and writes clear, accurate reviews of the literature.
  • Creates operational and system qualification documentation in support of Messaging Services implementation. Develops Standard Operating Procedures (SOPs), training materials, and user manuals.
  • Years of Experience 2-4
 
What is the minimum education experience required?   
  • 2-4 years of experience
  • Associates degree or Bachelor’s degree
  • Education in Biology or Microbiology would be best, but not a must
 

Skills required

Biotechnology
Life Sciences
Pharmaceuticals
Research
Technical Services
Good Manufacturing Practices
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Job ID: 19-11156

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