“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations tstaff augmentation external workers whqualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship tthis company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- cGMP experience
- Project Management experience
- Quality record management and investigational skill
- Strong Verbal and Written Skills
- Problem Solving and Critical Thinking
Enter data in buget spread-sheets; 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.
What you will do
Let’s do this. Let’s change the world. 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.
- 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
Bachelor's Degree and 2 years of Biotech/Pharma experience
Associate's degree and 6 years of Biotech/Pharma experience
High school diploma/ GED and 8 years of Biotech/Pharma experience
"This posting is for Contingent Worker, not an FTE"