- 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:** Experience + 5+ years of progressive experience in the Medical Informatics Sales. + Broad functional expertise in sales and experience in the areas of sales and marketing, strategic selling… more
- Grifols Shared Services North America, Inc (Jacksonville, NC)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- Sumitomo Pharma (Raleigh, NC)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Fujifilm (Holly Springs, NC)
- …ID systems (MALDI, MicroSeq) * Intermediate LIMS training * Knowledge or training of FDA regulations (cGMP, cGLP, cGDP) * Trackwise System training * Lean / 6S ... training **Physical and Work Environment Requirements:** Ability to discern audible cues. Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. Ability to ascend or descend ladders, scaffolding, ramps,… more
- Bausch + Lomb (Charlotte, NC)
- …prescription activity and potential growth + Utilizing available samples within FDA guidelines to maximize impact with promotional audience **Qualifications** + ... Bachelors degree in science, business or other related discipline required; a professional certification in related field combined with ophthalmic experience may be considered in lieu of a degree. + 3+ years experience in specialty pharmaceutical sales with a… more
- Kelly Services (Winston Salem, NC)
- …statistical software (eg, JMP). + Comprehensive understanding of regulatory requirements from FDA , EMA, and ICH guidelines relevant to biologics and cell therapies, ... with experience preparing IND and BLA submissions. + Familiarity with analytical techniques including flow cytometry, ELISA, and potency assays supporting process development and product release. + Proven project management skills, capable of managing multiple… more
- GRAIL (Raleigh, NC)
- …to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In addition, this individual will also be ... involved in the installation and start-up of new equipment and assist with any commissioning and qualification activity as required. This position will also support the Environment, Health, and Safety personnel (EHS) to ensure the systems are operated safely… more
- Fujifilm (Holly Springs, NC)
- …plumbing, chemical treatment, and control systems + Familiarity with GMP, FDA , and other regulatory requirements + Effective communication, both written and ... oral + Ability to work in a team environment + Willingness to coach, lead, and develop a team + Ability to effectively present information to others + Knowledge of Lean Six Sigma methodologies or other continuous improvement techniques + Must be able to work… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. + Ability ... to rapidly learn new procedures and reduce them to practice. + Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer. + Reasonable, reliable attendance and punctuality is an… more
- West Pharmaceutical Services (Kinston, NC)
- …manufacturing experience preferred + Experience working with ISO standards, FDA and cGMP required + Pharmaceutical manufacturing experience preferred + ... Proven ability to lead and organization in a highly regulated environment. **Preferred Knowledge, Skills and Abilities** + General knowledge of OSHA/EPA/safety regulations, manufacturing and process automation. + Familiartity with the operations and… more