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Specialist Quality Assurance (JP9283)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Quality Assurance (JP9283)
Location: Thousand Oaks, CA (Mostly remote work)
Employment Type:  Contract
Business Unit: 
External Supply Quality
Duration: 1+ years with likely extensions
Posting Date: 10/12/2021
3 Key Consulting is hiring a Specialist Quality Assurances for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:

The successful candidate will be involved in ensuring execution of applicable systems and processes in alignment with company standards. They will identify key issues, needs, constraints of the External Supply Quality/External Supply and drive network solutions for resolution. They will understand and interpret applicable GMP Regulations relating to supplier management and oversight of service providers ensuring existing process & procedures are fully aligned. They will provide tactical information to the networks (ie metrics to MR, data analysis, trending). They will drive continuous improvement with a One company mindset.

Why is the Position Open?
Planned project.
Top Must-Have Skill Sets:
  • cGMP Experience with demonstrated ability to consistently deliver on-time, and high-quality results
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to operate in a matrixed or team environment & operate in a matrixed or team environment
Day to Day Responsibilities:
  • Ensure execution of applicable Systems and Processes is in alignment with Operating Standards
  • Identify key issues, needs, constraints of the External Quality/Supply organization and drive network solutions for resolution
  • Understanding and interpreting of applicable GMP Regulations pertaining to the System or Process of which the SME is representing
  • Communicate and ensure alignment on priority decisions
  • Provide tactical information to the networks (i.e., metrics to MR, data analysis, trending)
  • Drive continuous improvements and One company mindset
Employee Value Proposition:
Great biotech/pharma to work for
Growing their skill set

Red Flags:

Insufficient experience, high turnover taking into account contract world.

Interview process:
1) Phone screen
2) Final panel (3) interview by video call

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 take a look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.

3KC Talent Acquisition Team
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