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Specialist Manufacturing (JP9403)

Thousand Oaks, Ca · Biotech/Pharmaceutical
Job Title: Specialist Manufacturing, FDA GMP (JP9403)
Location: Thousand Oaks, CA (one day/week onsite)

Employment Type: Contract
Duration: 6 months with likely extensions
Job posting date: 11/3/2021
Note: 
Remote until COVID restrictions are lifted but after restrictions once a week


3 Key Consulting is hiring a Specialist Manufacturing for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
In this vital role you will lead:
  • Manufacturing operations: Ensure accuracy and completion of data entries and/or tasks for budget development, monitoring, and reporting; inputs to contracts, confidentiality disclosure agreement(s), scope of work agreement(s), request for pricing/information, supply agreement(s) etc.
  • Own NC Class II/III records, CAPA, CAPA EV, and more complex change control records.

Site performance monitoring:
  • Report contract site performance metrics to site lead
  • Identify improvement opportunities for site performance
  • Daily duties will include coordination, issuance, and review of meeting minutes, conclusions from analysis of data and metrics, continuous improvement and standardization of performance tools used by the Work Center Teams (WCT), oversight and reporting of procurement/payment of invoices, and active participation in WCT meetings with the contract site as well as internal site team.
     
Project Management and Technology transfers:
  • Follow-up and track activities in a department-wide project from conception to implementation and close-out.
  • Manage timeline and highlight risks of transfer team activities; coordinate risk management activities as part of transfer; provide escalation to the right level.
     
Competencies
  • Demonstrated matrix management and influencing skills.
  • Manufacturing and cGMP knowledge / experience.
  • Demonstrated negotiation skills.
  • Operational Excellence proficiency and ability to drive continuous improvement.
  • Financial/budgeting knowledge and business acumen.
  • Proficient project management skills.
  • Problem-solving and critical thinking.
  • Understanding of contractual requirements.
  • Technical writing and multi-level communication skills.
  • Demonstrated ability to lead effectively in collaborative/team environment.
  • Demonstrated ability to take initiative, drive action, and work under minimum supervision.
     
Basic Qualifications:
  • Master's Degree OR
  • Bachelor's Degree and 2 years of Biotech/Pharma experience OR
  • Associate's degree and 6 years of Biotech/Pharma experience OR
  • High school diploma/ GED and 8 years of Biotech/Pharma experience

Top Must have Skill Sets:
  • cGMP experience
  • Project Management experience
  • Quality record management and investigational skill
  • Strong Verbal and Written Skills
  • Problem Solving and Critical Thinking

Day-To-Day Responsibilities:
Enter data in budget spreadsheets; routing/monitoring/tracking inputs to contracts confidentiality disclosure agreements, scope of work, request for pricing/information, supply agreement etc. Own Major and Minor Deviations, CAPAs and Change Controls, Supplier Notifications records.

Employee Value Proposition:
Grow their skill set
Fast paced environment


Red Flags:
PhD Degree – Over qualification
Someone who does not know how to work in an FDA regulated environment


Interview Process:
Phone interview
One panel video Webex 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 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.

 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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