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Specialist Manufacturing – Biotech QC (J7386)

Thousand Oaks, Ca, California · Biotech/Pharmaceutical
Job Title: Specialist Manufacturing – Biotech QC (J7386)
Location: Thousand Oaks, CA.
Employment Type:  Contract
Business Unit:  Medical Device Supply and Raw Materials
Duration: 12+ months (with likely extensions)
3 Key Consulting is hiring a Specialist Manufacturing Associate for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
Ideal Candidate- Previous Biotech experience. Preferably experience in a quality role. Seasoned self-starter, excellent communication, and interpersonal skills. This individual will be owning/executing change controls for Supplier changes. This will include coordinating team activities, making sure hitting milestones and on track with project plan.

Average person- Bio pharma experience or background sector with solid Project Management and Quality Management skills and experience.

The Specialist is expected to own Change Controls. Experience with managing multiple records is important and TrackWise user knowledge is an advantage.

May act as the External Supply Lead driving consistency across all Specialists in the space.

Will be required to communicate with many functions within the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.

May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites.
Why is the Position Open?
Additional workload.
Top Must-Have Skill Sets:
  • Quality Record Ownership
  • Project Management
  • Supply Chain Management

Day to Day Responsibilities:
  • Open and Close Change Controls.
  • Manage teams and tasks to manage Change Controls.
  • Schedule and Lead teams to execute Change Control tasks.
Basic Qualifications:
  • Master’s degree and 4 years of Quality and/or Manufacturing experience OR
  • Bachelor’s degree and 6 years of Quality and/or Manufacturing experience OR
  • Associate’s degree and 8 years of Quality and/or Manufacturing experience OR
  • High school diploma / GED and 10 years Quality and/or Manufacturing experience.
Preferred Qualifications:
  • 6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with progressively increasing responsibility and demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems.
  • Thorough understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations.
  • Thorough working knowledge of owning deviations, CAPAs, CAPA-EVs and change controls.
  • Demonstrated ability to work autonomously, present data in an organized and logical manner, and communicate effectively.
  • Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach.
  • Excellent interpersonal relationship skills.
  • Excellent oral and written communication skills.
  • Proficient with TrackWise; MSWord; MSExcel; MSPowerPoint.
  • Ability to maintain remote working relationships with colleagues at other corporate sites.
Employee Value Proposition:
Working and growing your skill set at a bio-tech company
Red Flags:
No Quality or Bio-Pharma experience
Interview process:
Phone screening 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 position, please feel free to 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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