Specialist Manufacturing

ApTask Global Workforce (AGW) is seeking a Specialist Manufacturing with a technology company. This is a 12+ month contract opportunity with our client located in Thousand Oaks, CA. This is an onsite position.

Responsibilities:

• Work with New Product Introduction (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
• Resolve issues in a timely manner and elevate cross-functional customer concern to various levels of management as appropriate
• Own Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures
• Proactively lead cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule
• Succinctly communicate verbally, in writing, and through presentations to peers and senior leadership team
• Engage with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s)
• Hold supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate
• Review protocols for manufacturing activities and partner with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses
• Identify improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities
• Perform purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies
• Report on team and plant metrics to ensure visibility to team operations and deliverables
• Represent the team at plant-wide and network-wide forums, as needed

• Doctorate degree OR Master's degree and 2 years of experience OR Bachelor's degree and 4 years of experience OR Associate's degree and 8 years of experience OR High school diploma / GED and 10 years of experience
• Cross functional project management experience
• Change control experience in a GMP environment
• Demonstrated independent problem solving ability
• Drug Product Manufacturing Experience

• 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.)

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.