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Quality Assurance Manager - Biotech (JP7977)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Quality Assurance Manager - Biotech (JP7977)
Location: Thousand Oaks, Ca (Remote work)
Employment Type: Contract
Business Unit: Corporate Quality Assurance
Duration: 12 months with likely extensions
Job posting date: 12/3/2020

3 Key Consulting is hiring a Quality Assurance Manager for a consulting engagement with our client, a leading global bio-pharmaceutical company.
Must have skills:
- Must have 4+ years computerized system validation experience
- Must have quality assurance experience
- Must have worked in a GxP are and understand regulations
Job Summary:
The Quality Assurance Manager 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.
Day to Day Responsibilities:
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
    o Qualitative information
    o Quantitative research
    o 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
Employee Value Proposition:
Very dynamic team. opportunity to learn many skills from various projects. Very flexible
Red Flags:
  • No quality experience
  • No computerized systems validation experience
  • Jumping from job to job

Interview Process:
Webex/Video Interviews
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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