• Title: Manufacturing Associate II
• Location: Raleigh- Durham, North Carolina
• Industry: Pharmaceutical
• Shift: Mon - Fri 8am - 5pm with some weekends
• Salary: Up to $30/hr. based on experience
• Employment Type: Contract to hire

Essential Duties and Responsibilities

• Proficient in Microsoft Word, Excel, PowerPoint, and other applications.
• Knowledge of aseptic processing/cell culture/cell therapy manufacturing in a cGMP setting.
• Maintaining personal responsibility with Personal Protective Equipment (PPE)
• Collaborate with the team to produce Standard Operating Procedures (SOP) or Manufacturing Batch Records.
• Ability to perform Quality Control evaluations in a manufacturing setting.
• Demonstrate the ability of material flow into the manufacturing cleanroom including disinfection.
• Be responsible for your own safety. Also, be accountable for meeting your own training responsibilities.
• Collaborate with the Investigation team to investigate Quality and Safety incidents.
• Develop a knowledge of GXP procedures (GMP, GLP, GCP, GDP, etc.)
• Must have the ability to clean equipment and manufacturing cleanrooms.
• Contribute to the team s success by sharing knowledge.

Qualifications

• High school diploma or equivalent and at least 2+ years of relevant education and experience.
• Must be able to work 40 hours per week and on weekends.
• Ability to work independently and stay on task in a fast-paced environment without direct supervision.
• Must be able to recognize when processes, procedures, equipment, products, materials, etc. are out of specification.
• Effective oral communication.
• Ability to work well with others in a collaborative team environment.
• Regular and reliable performance and attendance are required.
• Able to work in a rapidly changing climate reacts well to change.
• Must be able to perform mathematical calculations such as converting milliliters to liters or grams to kilograms.
• Understands significant figures and rounding.
• Must be able to lift up to 40+lbs.
• Must be able to stand and/or sit for extended periods.
• Manage your own time and professional development. Be accountable for your own results and prioritized workflows.

• B.S degree in Natural Sciences (i.e, Biology, Chemistry, etc.) or Engineering (Chemical, Biomedical, etc.) and 2+ years of manufacturing experience.
• cGMP clean room experience.
• An equivalent combination of education and experience may be considered.
• Have knowledge of cell and gene therapy processing, the metric system, and scales.
• Knowledge to initiate and drive to completion deviations, change controls, and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.