3 Key Consulting is hiring a Specialist Manufacturing for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description: 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.
Why is the Position Open? Supplement additional workload on team.
Top Must-Have Skill Sets:
Strong Verbal and Written Skills.
Project Management Skills.
Problem Solving and Critical Thinking.
Quality record management and investigational skills.
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.
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
Employee Value Proposition: The person in this role will work with a great team and gain experience working with external partners and gain understanding of manufacturing,
Someone who does not know how to work in an FDA regulated environment.
Video Skype Panel Interview
We invite qualified candidates to send your resume to firstname.lastname@example.org. 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.