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Sr Associate- Data Engineer (JP7669)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title: Sr Associate- Data Engineer (JP7669)
Location: Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 9 September 2020
Note: Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Sr Associate for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Job Summary:
  • Candidate will be working remotely until the site reopens.
  • Candidate will be working PST.
  • Must have Pharma or Biotech experience.
  • Purpose of role: support method and product trending, levitate quality system heavy work & supporting product control limits.

Job Description

The Attribute Sciences Data Engineering (ASDE) group provides scientific and technical engineering expertise in support of Client’s pipeline and commercial portfolio. This team applies advanced data & computational analytics to advance products across all stages of therapeutic development.

This position will provide support to Client’s’s pipeline through support of Client’s quality systems as it relates to commercial product quality data monitoring. This position will support the quality related activities within the ASDE group. Responsibilities will include Quality Record ownership, SOP revision, authoring of GMP reports, ad-hoc data transcription and data verification support as well as collaboration with a cross-functional team to understand the scope and needs of product quality leads within the product data monitoring program.

Day-To-Day Responsibilities:
  • Use Client’s quality systems (e.g., Trackwise) to document and coordinate the investigation into product data signals.
  • Own and revise SOP’s related to product data monitoring.
  • Author and revise reports summarizing the calculation of product data monitoring limits within Client’s Document Management system.
  • Provide data transcription and data verification support as needed for documents (e.g., Excel files)
Basic Qualifications
Master’s degree OR Bachelor’s degree and 2 years of scientific or engineering experience OR  Associate’s degree and 6 years of scientific or engineering experience OR  High school diploma / GED and 8 years of scientific or engineering experience

Preferred Qualifications
  • Experience and understanding of cGMP.
  • Experience in quality systems.
  • Experience with SOP authoring and revision.
  • Able to adapt to changing business needs and operational requirements.
  • Ability to deliver high quality results in a timely manner.
  • Excellent written and verbal communication.
  • Strong leadership skills and decision-making abilities
  • Demonstrated ability to work under minimal direction.
  • Ability to multi-task and function in a dynamic environment.
  • Ability to solve difficult, non-routine analysis problems, applying advanced analytical methods as needed

Top Must have Skill Sets:
  • Experience and understanding of cGMP
  • Experience in quality systems
  • Experience with SOP authoring and revision, 2+ years
Employee Value Proposition:
Opportunity to join a fast-paced team that applies advanced data & computational analytics to advance products across all stages of therapeutic development.
Red Flags:
No computer experience
Interview Process:
initial phone screen followed by video interview with additional team members.
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.
3KC Talent Acquisition Team
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