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Quality Assurance Senior Associate (JP7179)

West Greenwich, Rhode Island · Biotech/Pharmaceutical
Job Title: Quality Assurance Senior Associate (JP7179)
Location: 40 Technology Way, West Greenwich, Rhode Island 02817
Employment Type: Contract
Business Unit: Quality Control 
Start Date: 04/23/2020
Duration: 3 Years
Job posting date:4/2/20
 
3 Key Consulting is hiring a Quality Assurance Senior Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
 
Will assist with document review and initiate incidents, as well as coordinate and compile general documents and oversee room clearance inspection.; Skills: ; quality assurance or manufacturing experience in the pharmaceutical or medical device industry.

• Responsible for SM LIMS data coordination activities, including sample reconciliation and CoA generation.
• Responsible for management of SM LIMS approval based tasks; aligned to source documentation.
• Responsible for supporting validation activities for SM LIMS and associated quality document management.
• Responsible for data queries from QC’s electronic systems.
• Responsible for QC Assessor for Change Controls impacting analytical systems.
• Provides ownership and QA oversight for document management of various processes within QC.
• Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
• Supports inspection readiness activities across Quality Control, and site audits and inspections.
• Maintains project plan commitments supporting critical projects
• Supports Continual Improvement initiatives, programs and projects.
 

Top Must have Skill Sets:
  • Experience with SM LIMS (data reporting management system, laboratory information system).
  • Experience with system validation, specifically SM LIMS (system validation).
  • Quality Assurance oversight and record management, specifically deviations, corrective/preventive actions and effectiveness verifications (ownership of documentation, data entry verification).

    Soft Skills:
  • Project management.
  • Proficiency in Excel, Word, and Power Point.
  • Strong interpersonal skills
 
Employee Value Proposition:
Growing your skill set, great team culture.
 
Red Flags:
No previous quality assurance experience.
 
Interview Process:
Phone screening and skype interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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