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Specialist Quality Assurance (JP7739)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Specialist Quality Assurance (JP7739)
Location: Thousand Oaks, CA. (100% Remote)
Employment Type:  Contract
Business Unit: Corporate Quality
Duration: 18+ months (with likely extensions)
Posting Date: 10/2/20
3 Key Consulting is hiring a Specialist Quality Assurance for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
  • 2 positions available.
  • Candidate will be fully remote.
  • Open to any time zone - ideally PST.
  • Candidate will managing a system validation, not individuals.
  • 3+ years of QA with emphasis of computerized system validation.
  • Must have QA experience, Compliance experience, & Computerized system validation.
  • Pharma & Biotech experience must have.
The Specialist Quality Assurance will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques and procedures. In this position you will monitor validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation.
This individual will actively participate during all phases of qualification/validation: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities.
  • Review validation/qualification packages for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis.
  • Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
  • Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes.
  • Initiate, execute, and track completion of Change Control and Non Conformance requests related to computer systems. Participation and support of regulatory inspections.
  • Act as reviewer and approver for operational SOP’s and Work Instructions
  • Review of operational SOP’s and Work Instructions
  • Review and approve change controls and class I Non Conformances
  • Initiate and own QA Non Conformances as needed.
  • Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
  • Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
    • Qualitative information
    • Quantitative research
    • Trend data
  • Forecasts, models and utilizes advanced analytical tools
  • Anticipates and prevents potential problems
  • May be responsible for specific programs and/or projects
  • Independently develops solutions that are thorough, practical and consistent with functional objectives
Why is the Position Open?
Additional workload.
Top Must-Have Skill Sets:
  • Compliance.
  • Computerized System Validation.
  • Quality Assurance Experience.
Employee Value Proposition:
Opportunity to join a fast-paced team.
Red Flags:
Jumping from job to job.
Interview process:
Video Skype Panel 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/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team

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