Manufacturing Associate II
4 days ago
Lynkx Staffing LLC is seeking a highly skilled and detail-oriented Manufacturing Associate II to join our team in the biotechnology industry. As a key member of our production team, you will be responsible for processing, culturing, and manipulating cell products using aseptic techniques, adhering to written Standard Operating Procedures and facility GLP, GTP, and GMP practices.
Key Responsibilities- Perform aseptic processing and manipulation of cell products, adhering to SOPs and facility regulations.
- Work in ISO Class 7 and 6 clean room environments, ensuring personal and product safety.
- Produce high-quality documentation, including batch records and standard operating procedures.
- Operate and maintain complex equipment, including COBE 2991 cell washers, Clinimacs cell separators, and controlled-rate freezers.
- Participate in clinical trial support and studies, including sample preparation, shipping, and media preparation.
- Thaw and wash cryopreserved hematopoietic cell products, adhering to SOPs.
- Perform facility and equipment duties, including maintenance, troubleshooting, and reporting.
- Investigate deviations and complete CAPAs in a timely manner.
- Support technology transfers into GMP manufacturing operations.
- Bachelor's or Associate's degree in a biologics or related field.
- 2-4+ years of experience in a clinical laboratory, hematology, blood banking, immunology, or cGMP manufacturing.
- Current Medical Technologist license or equivalent.
- Aseptic/cell processing and clean room experience preferred.
- Strong work ethic, methodical approach to new challenges.
- GLP and GMP experience a plus.
- Ability to work independently and with minimal supervision.
- Excellent organizational skills and attention to detail.
- Good verbal and written communication skills.
- Strong team-oriented interpersonal skills.
- Ability to think strategically and tactically.
- Strong analytical and problem-solving skills.
- Ability to work a flexible schedule, including nights, weekends, and holidays.
Lynkx Staffing LLC is committed to providing a safe and healthy work environment for all employees. As a Manufacturing Associate II, you will be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids. You will be required to utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen.
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