- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …Strong understanding of current GMPs and related regulatory health authority guidance ( FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical ... industry. + Must be proactive, results-oriented with a strong attention to detail and strong time management skills. + Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment. +… more
- Fluor (Raleigh, NC)
- …or healthcare equipment. + Strong understanding of regulatory requirements, including FDA guidelines and ISO standards. + Strong understanding of BIM/3D design ... tools and other relevant design tools. + Excellent leadership and team management skills. + Effective communication and interpersonal skills, with the ability to collaborate across different teams and levels of the organization. + Strong problem-solving… 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. **Qualifications:** Baseline Qualifications: + Bachelor's Degree, Trade School Certification (Industry related), or Industry Experience Equivalent + One or more industry-specific certifications in relevant… more
- Fujifilm (Holly Springs, NC)
- …* Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC ... AD team to investigate any project challenges with necessary risk assessment tools and techniques * Support best practices for TT and PPQ strategies globally, as required * Performs other duties, as assigned **Minimum Requirements:** * BS in Chemistry,… more
- ThermoFisher Scientific (Greenville, NC)
- …important regulatory considerations governing adverse event reporting and experience with FDA , EMA and other national and international regulatory authorities + ... Experience as a medical strategy leader for multidisciplinary teams with mastery of medical management tasks (review AEs, protocol inquiries, listings, diagnostic reports, data trending, etc.) and/or safety tasks (signal detection activities, aggregate report… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility **Preferred Requirements:** * 2+ years of experience in ... GMP Quality Assurance and/or similar role * Experience and working knowledge of ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software **Working Conditions & Physical Requirements:** + Ability to discern audible cues + Ability to… more
- Novant Health (Winston Salem, NC)
- …policies and procedures, as well as regulatory requirements (ex. FDA , FACT). + Administers pre-transplant conditioning chemotherapy regimens and pre-CAR ... T lympho-depleting chemotherapy. + Performs hematopoietic cell transplantation and cellular product infusions. + Maintains and cares for patient venous access used during apheresis procedure. + Monitors patients daily post-transplant and post-CAR T.… more
- BioLife Plasma Services (Raleigh, NC)
- …wear **Preferred Qualifications** + Familiarity with SOPs, GDP, GMP, CLIA, and FDA regulations + Experience working in a regulated industry or high-compliance ... environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company-paid holidays + Tuition reimbursement + Retirement… more
- ThermoFisher Scientific (High Point, NC)
- …Follow quality standards in accordance with company policy and cGMP and FDA requirements. Understanding of cGxP requirements. + Troubleshoot & support manufacturing ... equipment and facility equipment. + Perform preventive and predictive maintenance. + Perform alternating or rotating shift work as well as requirement to work during maintenance shutdowns. + Provide emergency/unscheduled repairs of production equipment to… more
- Teleflex (Morrisville, NC)
- …* Strong understanding of industry regulations such as ISO 13485, ISO 14971 and FDA 21CFR820. * Proficient in MS Office, and Minitab or other statistical softwares. ... * Strong organizational and time management skills to meet deadlines while managing multiple projects. * Strong analytical and critical thinking skills. * Proficient in technical report writing and review. * Strong verbal and written communication skills. *… more