- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six… more
- Novo Nordisk (Clayton, NC)
- …utility and raw material systems, as well as working in a regulated environment ( FDA , cGMP, OSHA) a plus + Experience demonstrating a systematic approach to problem ... solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred + Basic knowledge of production utility systems or raw… more
- Mentor Technical Group (Durham, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Mentor Technical Group (Monroe, NC)
- …provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical ... solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …**Knowledge, Skills, & Abilities:** Comprehensive knowledge and understanding of FDA and global regulatory requirements for regulatory pathways and strategies ... for development projects in the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written communication skills. Strong critical thinking and problem solving… 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 * Good computer skills * Ability to operate laboratory equipment and computers * Ability to take direction from experienced scientists and contributes in a team environment * Good… more
- ThermoFisher Scientific (Greenville, NC)
- …or Customs Broker license. + Knowledge of pharmaceutical regulatory standards ( FDA , DEA) is a plus. + Strong analytical, problem-solving, and organizational ... skills with attention to detail. + Ability to lead cross-functional teams and develop a culture of compliance. **Physical Demands & Work Environment:** + Occasional lifting, bending, and extended standing. + Fast-paced environment with multiple priorities. +… more
- Lilly (Concord, NC)
- …in manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM degree or certification + ... Aseptic filling, single use assemblies, isolator technology. + Automated, semi-automated, and/or manual inspection. + Highly automated equipment (inspection, packaging, filling, assembly, etc.) + Manufacturing Execution Systems and SAP or other electronic… more
- HCA Healthcare (Asheville, NC)
- …with standards set forth by accrediting agencies: CAP, JCAHO, CLIA, FDA and CMS. Leads department accreditation preparation. + Oversee quality control/assurance ... programs related to test methodology, protocols, equipment and supplies. + Actively participates in Continuous Quality Improvement. + Ensure that staff receives information by developing and implementing a communication plan. You Should Have: + Bachelor's… more
- Kelly Services (Winston Salem, NC)
- …manufacturing, or medical device industry. + Strong understanding of cGMP, GxP, and FDA regulations. + Familiarity with bioassays and raw material testing methods. + ... Experience with LIMS or other electronic quality/data systems. + Experience with deviation handling, change control, and OOS investigations. + Subject matter expertise in relevant analytical assays. + Strong communication skills and ability to work… more