- Insight Global (Holly Springs, NC)
- …- Bachelors Degree in Engineering or related field - Experience with cGMP documentation and validation life cycle - Experience writing cleaning validation reports, ... risk assessments, protocols and investigating and resolving deviations - Experience with Kneat high preference for this - Experience with greenfield, brownfield or new facility build outs desirable Pluses: - Cleaning validation experience with both small parts… more
- Amgen (Holly Springs, NC)
- …+ Knowledge and experience working in a highly regulated function - cGMP . + Experience executing and documenting maintenance work orders in a computerized ... maintenance management system. + Ability to interpret P&ID's. + Ability to work with minimum direction. + Ability to effectively communicate issues and status of tasks in a timely manner. + Ability to interact constructively with peers/teams. **What you can… more
- Lilly (Durham, NC)
- …for mastering technical concepts. + Solid understanding of FDA guidelines and CGMP standards. + Ability to effectively communicate (written and verbal). + ... Flexibility and problem-solving skills. + Basic computer skills (desktop software) are required. **Other Information:** + This role will train on day shift initially. + The position is for the Lilly Research Triangle Park site. + Ability to wear safety… more
- Fujifilm (Holly Springs, NC)
- …years of people management/ leadership experience + Prior experience working in a CGMP facility + ISA-S88 + ISA-S95 **Preferred Requirements** + Master's degree in a ... technical field of study relevant to Automation, Instrumentation & Controls, or Business Management with 9+ years of related experience in a regulated industry + Experience with Lean Six Sigma or other continuous improvement methodologies + ISA-S18.2 **WORKING… more
- Fujifilm (Holly Springs, NC)
- …years of people management/ leadership experience + Prior experience working in a CGMP facility + ISA-S88 + ISA-S95 **Preferred Requirements** + Master's degree in a ... technical field of study relevant to Automation, Instrumentation & Controls, or Business Management with 9+ years of related experience in a regulated industry + Experience with Lean Six Sigma or other continuous improvement methodologies + ISA-S18.2 **WORKING… more
- WestRock Company (Claremont, NC)
- …as well as a physical examination. * Background check is required. * Must complete cGMP and Departmental QOP training. * Must be able to read and comprehend simple ... instructions and short correspondence as well as write simple correspondence. * Ability to effectively present information in one-on-one situations and in small group situations to customers and other employees of the organization. * Adequate mathematical… more
- Fujifilm (Holly Springs, NC)
- …Bachelor's in life sciences or engineering + BioWorks or BTEC Capstone cGMP coursework preferred **Physical Requirements & Working Environment** + Ability to discern ... audible cues. + Ability to stand for prolonged periods of time - up to 120 minutes + Ability to sit for prolonged periods of time + Ability to conduct activities using repetitive motions that include writs, hands and/or fingers + Ability to conduct work that… more
- Amgen (Holly Springs, NC)
- …highly regulated environment. + Experience working in a regulated environment (eg cGMP , OSHA, EPA, etc.) and experience interacting with regulatory agencies and ... inspectors. + Familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation + **Solid understanding of the following routine engineering tasks and systems:**… more
- 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