- Kedplasma (Hickory, NC)
- …exams** to assess donor eligibility in accordance with FDA, SOP, and cGMP regulations + **Administer immunizations** and monitor donor responses + Provide ... **first-line treatment** for donor adverse reactions (eg, hypotension, allergic responses) + Ensure thorough and accurate **documentation of donor health information** + Guide donors through the **informed consent** process with clear, compassionate… more
- Lilly (Durham, NC)
- …create, modify, edit tools, etc + Working knowledge of FDA Regulations including cGMP + Working knowledge of ISO standards, IEC standards and industry best ... practices. + Working knowledge of Preventive and Predictive Maintenance techniques, including but not limited to Tribology, Vibration Analysis, Thermography, Life Cycle Cost Analysis, equipment installation requirements, etc. + Ability to make individual,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …job plans and/or equipment manuals to perform work + Adhere to cGMP , Safety, and Environmental procedures + Issue/complete job hazard analysis/safe work permits ... (hot work, excavating, confined space, hazardous atmosphere, etc.) + Responsible for maintaining training curriculum requirements + Complete required in-house Maintenance Qualifications + Assist with modification, installation and startup of new and existing… more
- Reckitt (Wilson, NC)
- …and support of smart automated systems within a tightly regulated cGMP environment. Your mission: engineer solutions that streamline processes, enhance data ... integrity, and raise the bar for compliance-all while fueling innovative capital projects and day-to-day operations. **Your responsibilities** + Lead design, implementation, and lifecycle management of control systems (PLC, HMI, SCADA, DCS) for manufacturing /… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …manufacturing operations with minimum downtime and cost effectiveness. + Comply with all cGMP , OSHA, and Environmental & Safety policies and procedures. + Promote a ... culture of ownership of equipment and one's area of responsibility. + Maintain a rapport with Human Resources to ensure compliance with applicable internal policies and practices as well as promotions, recruitment activities, performance management, etc. +… more
- Catalent Pharma Solutions (Morrisville, NC)
- …steps and processes necessary for preparation and finishing of experimental and cGMP product batches + Interact and communicate with internal and external customers ... on equipment, materials, and processes + Maintain accurate inventory and tracking records of supplies and equipment + Fill product in aseptic processing area in compliance with SOPs, batch record, and cGMPs + All other duties as assigned **The Candidate:** +… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …within warehouse and manufacturing operations. This position ensures compliance with cGMP , ISO, FDA regulations, company policies, and safety guidelines while ... overseeing the physical movement, storage, and replenishment of all material types. Responsibilities include receiving, shipping, storing, and supporting Manufacturing through timely replenishment activities. Utilizing Warehouse Management software, this role… more
- ThermoFisher Scientific (Greenville, NC)
- …preferably in a scientific related field. + 5+ years of experience in a cGMP manufacturing or QA Operations environment with strong knowledge of GMP operations and ... regulations. + 2+ years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry. + 2+ years supervisory/leadership experience required. + Equivalent combinations of education, training, and relevant work… more
- ThermoFisher Scientific (Greenville, NC)
- …and client-facing roles. + Outstanding technical writing skills + Influencing + cGMP Compliance + Strong sense of diplomacy and assertiveness + Quality Judgement ... + Effective time management and prioritization skills. + Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. + Outstanding attention to… more
- Amgen (Holly Springs, NC)
- …and continuous improvement initiatives. The role ensures alignment with cGMP standards, regulatory expectations, and Amgen's global quality systems. **Strategic ... Leadership** + Lead and develop a high-performing QC support team with expertise in lab operations, documentation, and compliance systems. + Drive alignment between site QC operations and global Amgen quality policies and procedures. **Quality Systems and… more