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Specialist Manufacturing

US Tech Solutions, Inc.

Thousand Oaks, CA

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JOB DETAILS
SALARY
$38–$45.47 Per Hour
SKILLS
Business Case, Change Control, Change Management, Communication Skills, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, Drug Products, GMP (Good Manufacturing Practices), High School Diploma, Leadership, Maintain Compliance, Management Strategy, Manufacturing, Metrics, Multitasking, People Management, Presentation/Verbal Skills, Problem Solving Skills, Process Development, Process Improvement, Product/Service Launch, Project Planning, Project/Program Management, Quality Assurance, Regulations, Risk Management, Standard Operating Procedures (SOP), Team Lead/Manager, Team Player, Technical Leadership, Technical Writing, Time Management, Writing Skills
LOCATION
Thousand Oaks, CA
POSTED
30+ days ago
Duration: Contract 12 months
 
Note:
100% Onsite
Standard business hours, M-F 8-5pm PST
 
Description:
The NPI Lead will be primarily responsible for:
  • Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
  • Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
  • Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
  • Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
  • Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
 
Additional Responsibilities include:
  • Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
  • Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
  • Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
  • Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
  • Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
  • Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
  • Representing the team at plant-wide and network-wide forums, as needed.
 Preferred Qualifications:
  • Project Management experience
  • Direct and/or indirect people management / leadership experience
  • Understanding of Drug Product Formulation and Vial/Syringe Filling operations
  • Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
  • Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
  • Independent, self-motivated, able to multi-task in a fast-paced environment
  • Team-player
  • Demonstrated flexibility and ability to manage change
  • Direct experience with regulated environments (e.g., cGMP etc.)
 Basic Qualifications:
  • Doctorate degree OR
  • Masters degree and 2 years of experience OR
  • Bachelors degree and 4 years of experience OR
  • Associates degree and 8 years of experience OR
  • High school diploma / GED and 10 years of experience.
 Top 3 Must Have Skill Sets:
  • Cross functional project management experience
  • Change control experience in a GMP environment
  • Demonstrated independent problem solving ability
  • Drug Product Manufacturing Experience
 
Day to Day Responsibilities:
  • Tech transfer project management, change control ownership
  • Lead multiple tech transfers in parallel and provide updates to management on status
  • Input metrics on status of tech transfers
  • Independently problem solve and filter issue escalations.
 
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
 
"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"

About the Company

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US Tech Solutions, Inc.