- Amgen (Holly Springs, NC)
- …manufacturing methodologies and continuous improvement. + Knowledge of relevant regulations (eg, FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH ... Q7). **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey… more
- Honeywell (Charlotte, NC)
- …initiatives in pharma or biotech. + Familiarity with global regulatory frameworks (eg, FDA , EMA, ISO). + Exposure to AI/ML, data analytics, or cloud platforms in ... life sciences. The annual base salary range for this position is $219,000- $275,000. Please note that this salary information serves as a general guideline. Honeywell considers various factors when extending an offer, including but not limited to the scope and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …utility systems. + These new utility systems are to support the FDA licensed blood fractionation, purification, and filling operations. Pharmaceutical experience is ... not required but shall be considered a plus for the candidate. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties,… more
- Emerson (Durham, NC)
- …Experience with regulatory/compliance documentation and procedures * Knowledgeable in FDA validation requirements preferred, including User Requirement and Design ... Specs, Business Process Procedures, Design Reviews, Requirements gathering * Experience with GAMP5 * Knowledge of PMI Project Management framework. * Knowledge of MES systems **Our Culture & Commitment to You** At Emerson, we prioritize a workplace where every… more
- Lundbeck (Asheville, NC)
- …including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. ... **REQUIRED EDUCATION, EXPERIENCE and SKILLS:** + Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university + 2-5 years pharmaceutical, biopharmaceutical, biologics, medical device sales or related healthcare sales experience. +… more
- Compass Group, North America (Charlotte, NC)
- …* Support educational nutrition campaigns * Executing operational standards * Managing FDA regulation standards * Market Research * Manage website and social ... networking profile content * Maintain cohesive database of all food safety metrics that can be used for tracking and trending compliance * Conduct routine food safety self-inspections * Conduct one-on-one or group food safety training sessions * Work with… more
- The Clorox Company (Durham, NC)
- …years specifically in the cosmetic and personal care space. + Strong knowledge of FDA regulations [e.g., The Food Drug and Cosmetic Act (FD&C Act), Modernization of ... Cosmetics Regulation Act (MOCRA)], global regulatory frameworks (including European Union, Canada and Asia markets), and OTC drug regulations/monographs. + Proven ability to lead project regulatory strategies and influence cross-functional teams. + Excellent… more
- Reckitt (Wilson, NC)
- …frameworks. + Ensure documentation adheres to GDP standards and regulatory compliance ( FDA , ICH, ISO); support validation and hygiene design requirements. + Develop ... and manage project budgets, cash flow forecasts, and detailed implementation schedules for tableting and coating scope. + Mentor junior engineers and technicians in tablet manufacturing and coating operations. + Generate and manage engineering documentation… more
- Jacobs (Cary, NC)
- …locations Ideally, you'll also have: * Proposal development experience * Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations * Knowledge of industry ... guidance: o ISPE Baseline Guide 5 Commissioning and Qualification o ISPE GAMP V, A Risk Based Approach to Compliant GMP Computerized Systems o ASTM E2500 Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical… more
- Charles River Laboratories (Raleigh, NC)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
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