Manufacturing Associate - The Staffing Resource Group, Inc
Durham, NC 27709
About the Job
Manufacturing Associate II
- 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
As a Manufacturing Associate II, you will be operating automatic and manual cell therapy equipment with a variety of complexity in CAR-T, CAR-M, or CAR-NK processes in accordance with standard operating procedures and policies. You will perform quality control analyses as required to complete in-process batches and identify variations. You will be trained in handling hazardous materials and emergency procedures since you will be handling leukapheresis cellular materials.
Essential Duties and Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.- 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
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.Required:
- 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.
Preferred:
- 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.
EOE/ADA
Source : The Staffing Resource Group, Inc