- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards. + Ensure Management Reviews are conducted to provide for systems review. + Manage Internal Audit Program. New/Change Product/Process Validation +… more
- CSL Plasma (Winston Salem, NC)
- …donor disconnect. + In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. + Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more
- BioLife Plasma Services (Raleigh, NC)
- …or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + ... Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** + BA/BS or equivalent, preferably with… more
- Kedplasma (Hickory, NC)
- …evaluations** and **physical 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,… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. a. Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... Directions. b. Ensures the most recent information related to maintenance and reliability is communicated and/or documented for compliance, history, and reliability. c. Strive towards continuous improvement of Preventative Maintenance procedures in pursuit of… more
- Lilly (Durham, NC)
- …(Cognex, Keyence) to 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… more
- Teleflex (Morrisville, NC)
- …blueprint reading preferred. * Experienced in medical device purchasing or FDA -regulated products preferred \#LI-AD1 _At Teleflex, we follow a comprehensive hiring ... process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front._ _Teleflex Incorporated is an equal opportunity employer. Applicants… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and mastering manual and automated testing procedures conducted within an FDA regulated GMP/GLP environment. Performs biological testing of moderate to advanced ... complexity within the **QC Biochemistry Laboratory Animal Facility.** Manual Laboratory testing methods revolve around animal testing using rabbits, guinea pigs, and mice. Animal handling experience is required. Responsibilities also include sample… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …and mastering manual and automated testing procedures conducted within an FDA regulated GMP/GLP environment. Performs biological testing of moderate to advanced ... complexity within the QC Biochemistry Laboratory. Manual Laboratory testing methods revolve around 96 well, plate-based testing, using single and multi-channel pipettes for serial dilutions. Other testing procedures involve automated analyzers for… more