- BD (Becton, Dickinson and Company) (Mebane, NC)
- …+ Basic knowledge of SAP is preferred. + Experience working in an FDA regulated environment is highly desirable. **Knowledge and Skills:** + General Proficiency in ... and articulate risk when evaluating a situation. + Knowledge of basic validation , equipment calibration, and change requirements. + Demonstrated understanding of the… more
- Merck (Durham, NC)
- …cross-functional team with executing and approving change controls. + Approve cleaning validation documentation as needed. + May act as a Quality Risk Assessment ... environment, or related industry including two (2) years of experience in an GMP or FDA regulated industry.** * **Schedule: Monday - Friday, 6:00 AM - 2:30 PM EST… more
- Teleflex (Morrisville, NC)
- …adherence to all relevant IT policies, procedures, and computer systems validation standards Team Leadership * Develop a best-in-class, diverse, Applications ... meeting project objectives * Strong communication skills * Experience in an FDA regulated environment preferred * Project Management and/or Lean Six Sigma… more
- Chiesi (Cary, NC)
- …rules for transformations + Develop and implement data quality checks and validation procedures to maintain data integrity. + Monitor data pipelines for ... Knowledge: Familiarity with pharmaceutical industry regulations and compliance requirements (eg, GxP, FDA 21 CFR Part 11, GDPR, etc.) + Attention to detail: Is… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …proceed with proper decision making + Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. #biojobs more
- BioFire Diagnostics, LLC. (Durham, NC)
- …+ Work with other departments and assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation ... OSHA regulations (LOTO, electrical safety, etc.) preferred. + Knowledge of FDA and/or GMP regulations preferred. + Mechanical background preferred. #biojobs more
- ITG Brands (NC)
- …regulations + Ensure projects adherence to regulatory compliances, including Group & FDA . + Awareness of evolving legislation relevant to machinery installations & ... process and how to generate manufacturing control plans. + Generation of validation master plans and manufacturing control plans. + Large manufacturing facilities… more
- ThermoFisher Scientific (Wilmington, NC)
- …sites. + Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess ... + Excellent interpersonal, influencing and team building skills + Understanding guidelines ( FDA , ICH, EMA and GCP) + Working knowledge of biostatistics, data… more
- Catalent Pharma Solutions (Greenville, NC)
- …organizations (CMOs and CPOs). **The Role** + Act as Commercial QA SME during FDA , non-domestic and client audits and lead preparation of responses to all audit ... cross-functional teams, such as Technical Services, facilities, Engineering and Validation . + Demonstratable leadership experience at Catalent (including but not… more
- Fujifilm (Holly Springs, NC)
- …and other applicable regulatory requirements (eg, Food & Drug Administration ( FDA ), Occupational Safety and Health Administration (OSHA) regulations, and cGMP) + ... Site Acceptance Test (SAT), Factory Acceptance Test (FAT), Commissioning and Validation protocols) + Strong knowledge of computerized maintenance management system… more