- Fujifilm (Holly Springs, NC)
- …validated per standards and regulatory requirements (eg, Food & Drug Administration ( FDA )) * Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems ... in the field * Drafts and implements validation protocols * Executes validation activities (eg, equipment set up, material readiness, and work orders) * Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized… more
- Veterans Affairs, Veterans Health Administration (Garner, NC)
- …medical devices and clinical systems such as Food and Drug Administration ( FDA ), Federal Information Security Modernization Act (FISMA), and National Institute of ... Standards and Technology (NIST) guidelines. (f) Ability to apply information security tools including virus protection, software updates, and operating system patches. (g) Ability to establish a medical network including VLAN configuration, Internet Protocol… more
- Veterans Affairs, Veterans Health Administration (Asheville, NC)
- …medical devices and clinical systems such as Food and Drug Administration ( FDA ), Federal Information Security Modernization Act (FISMA), and National Institute of ... Standards and Technology (NIST) guidelines. Ability to apply information security tools including virus protection, software updates, and operating system patches. Ability to establish a medical network including VLAN configuration, Internet Protocol… more
- Catalent Pharma Solutions (Greenville, NC)
- …regulations + Working knowledge of current Good Manufacturing Practices (cGMPs) and FDA /industry standards + Demonstrated ability to be a creative and proactive ... contributor and a strong focus on continuous improvement and safety culture enhancement + Must be able to safely move filled 55-gallon drums, manipulate objects, and perform physical tasks such as bending, squatting, climbing, and standing for extended… more
- ThermoFisher Scientific (Greenville, NC)
- …: Familiarity with relevant industry standards and regulations (eg, ISO, FDA , GMP) is highly desirable. + **Certifications** : Relevant certifications (eg, ... ISTQB, ASQ) are a plus. We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation,… more
- J&J Family of Companies (Wilson, NC)
- …with QC analytical equipment is required. + Knowledge of cGMP regulations and FDA /EU guidance is required. Other Requirements: + An unquestionable level of integrity ... and commitment to operating ethically and within the boundaries of regulatory requirements. + Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to… more
- United Therapeutics (Raleigh, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Cambrex High Point (Durham, NC)
- …to read and execute compendial methodologies + Strong understanding of current FDA and cGMP regulations + General knowledge of chemistry and scientific calculations ... + Hands on experience in analytical techniques such as HPLC, GC, etc + Strong computer skills + Ability to operate laboratory equipment and computers + Ability to take direction from experienced scientists and contributes in a team + Environment + Ability to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) OR Three years of warehouse experience in a ... non-regulated industry. Work is performed in a warehouse environment. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling, crawling… more
- Kedplasma (Hickory, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the… more
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