- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …+ Execute technology transfer of analytical methods for new products. Execute cleaning validation of new products. + Assist in the monitoring of changes in the ... Critical Investigations to align with corporate guidelines. + Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct. +… more
- Reckitt (Wilson, NC)
- …/ utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. + Validate and maintain ... cutting-edge technologies for performance optimization. + Drive regulatory alignment (GMP, FDA , ISO, EHS) across automation activities and support audits, … more
- Fujifilm (Holly Springs, NC)
- …of Drug Substance Manufacturing processes. This role provides oversight of validation program execution for these processes and systems to ensure applicable ... experience * 1-3 years' experience in a GMP environment * Experience in Validation , cGMP manufacturing operations and/or Quality oversight, in an FDA regulated… more
- ThermoFisher Scientific (Greenville, NC)
- …+ Proven understanding of **multivariate statistical analysis** , data preprocessing, and validation methods + Familiarity with **GMP** , FDA /EMA guidelines, and ... a Manufacturing Scientist, you will contribute to the development, validation , and optimization of chemometric models for oral solid...ICH standards related to PAT and model validation + Experience with **process control** , **model monitoring**… more
- Lilly (Durham, NC)
- …within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection ... documents (Global Q standards, Common Q practices, ) and execution documents ( validation reports, PoDs ) to support the visual inspection Quality System.… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... + Execute processes to ensure systems and/or solution achieve and maintain validation and/or qualification in accordance with regulations and guidance from the… more
- Reckitt (Wilson, NC)
- …engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA , ISO, EHS) and current schematics. + Execute preventive maintenance and ... support audits, validation , and tech transfers. + Resolve complex issues and...and electrical codes..Strong knowledge of regulatory standards (eg, GMP, FDA , ISO 9001/13485). + PE (Professional Engineer) License or… more
- Lilly (Concord, NC)
- …storage equipment commissioning (ASRS/AGV) and qualification activities, commercial product validation and ultimately be responsible for the physical handling of ... in quality initiatives and audits. Provides leadership for compliance to FDA , OSHA, EPA regulations. + Identifies and implements performance improvements +… more
- Cambrex High Point (Durham, NC)
- …area + Supports team to ensure proper creation of test methods, validation reports, stability protocols and reports, and (where required) development reports in ... accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity,...Strong understanding of basic lab techniques* Good understanding of FDA , EU and ICH requirements and implementation for GLP… more
- United Therapeutics (Morrisville, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... and Swine Leukocyte Antigen) laboratory, including assay development and validation studies, training and supporting technologists, maintaining QC/QA documentation… more