Senior Associate QA (JP4912)

Location: Thousand Oaks, ca
Date Posted: 11-01-2018
Job Title:  Senior Associate QA (JP4912)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit: External Supply Quality
Duration: 1+ years (likely extensions)
 
3Key Consulting Inc. is recruiting for a Senior Associate QA with 1 - 3 years’ experience in Office 365, biotech and a Master’s degree in a scientific discipline, related field. for a global, CA-based, bio-pharmaceutical company.
 
Job Description:
The successful candidate will provide project management support and execution of tasks to drive the implementation of assigned projects and key deliverables in Amgen’s External Quality organization. Working cross functionally with Contract Manufacturing and Raw Material organizations to execute projects related to External Supplier Quality and improvement of our cGMP Quality Systems.
 
Top Must-Have Skill Sets:
  • Project management.
  • Work both independently and in a team environment.
  • Working understanding of GMPs and compliance.
 
Day to Day Responsibilities
  • Drive and personally execute the implementation tasks of External Supplier Quality improvement projects.
  • Basic understanding of the cGMPs.
  • Working understanding of project management.
  • Follow Current Good Manufacturing Practices (cGMP) regulations and Amgen policies and procedures.
  • Work both independently and in a team environment.
  • Able to follow step-by-step instructions, revise cGMP documentation and perform repetitive functions consistently and accurately.
  • Work in a rapidly changing and demanding environment.
  • Strong attention to detail, including the ability to proofread documents and accurately transcribe data.
  • Additional projects, as assigned; Skills: administrative support experience; experience using MS Outlook, SAP/ERP Word, Excel, and PowerPoint in an office setting.
 
Basic Qualifications:
Project management skills.
Basic Understanding of cGMPs
 
Why This Position Is Open:
Planned project - departmental projects to build quality system efficiencies.
 
Employee Value Proposition:
Someone who is interested in improving efficiencies. Working in a regulated environment at a top pharmaceutical company.
 
Red Flags:
  • Lacking attention to detail.
  • No background in GMP.
  • No project management.
 
Interview process:
Phone followed by in-person interview.
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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