- HCA Healthcare (Asheville, NC)
- …including, but not limited to HSPA, CBSPD, AORN, The Joint Commission, FDA , CDC, OSHA, and AAMI. **What qualifications you will need:** Preferred Education: ... Bachelors in a healthcare related field preferred Required License/ Certifications: Current certification as a Sterile Processing Technician through an accredited organization. Preferred License/ Certifications: CRSCT, HSPA, CBSPD, NBSTSA, ASPT Required… more
- Fujifilm (Holly Springs, NC)
- …role, required + 3+ years of experience in GMP operations in an FDA regulated facility **Preferred Requirements:** + Experience and working knowledge of ASTM E2500, ... Smartsheet, Trackwise, Veeva, SAP, and/or Kneatvalidation software + Previous biopharmaceuticals experience: + Cell culture, upstream processes, large scale recovery + Experience with startup projects or initiative + Training and/or familiarity with Quality… more
- ThermoFisher Scientific (Greenville, NC)
- …eg, pharmaceuticals, manufacturing, etc.]. + Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. + Strong analytical and problem-solving ... skills. + Excellent communication and interpersonal skills. + Proficiency in quality management systems (QMS) and relevant software tools. **Preferred Qualifications:** + Certification in Quality Management (eg, Six Sigma, ASQ). + Experience with electronic… more
- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. **Preferred Requirements:** * Working knowledge and experience ... with ASTM E2500, Smartsheet, Trackwise, MasterControl and/or Kneat validation software * Experience with startup projects or initiatives **Physical and Work Environment Requirements:** Ability to discern audible cues. Ability to stand for prolonged periods of… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …+ Coordinates and organizes final responses to regulatory inspections / audits ( FDA , EMA, CLIA/COLA, PPTA, State, Health Canada, internal compliance audits). + ... Supports donor centers with customer audits, completes requested customer-driven documents, and assists with development of audit responses. + Ensures donor center and corporate operations are compliant with Domestic / European regulations through routine… 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 ... observations, particularly those related to Commercial Quality Assurance findings. + Lead site cross-functional team effort to drive all commercial CAPA commitments for audit responses and eQMS events to timely completion and effectiveness evaluation. + Lead… more
- Eliassen Group (Raleigh, NC)
- …actions + Ensure all written materials align with company, quality, and FDA guidelines across all manufacturing components **Experience Requirements:** + Ability to ... manage competing priorities + Overall understanding of process instructions + Life Science Experience + Software Skills Required: MS Platform Suite, Oracle, Coupa + Functional knowledge of Engineering/Maintenance + Maximo or Asset Management EAM platforms… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …and improves procedures and Preventative Maintenance Activities. + Adherence to FDA Regulations, GMP, ISO, HSE (OSHA), Department Procedures, and Manufacturing ... Directions. + Ensures the most recent information related to maintenance and reliability is communicated and/or documented for compliance, history, and reliability. + Strive towards continuous improvement of Preventative Maintenance procedures in pursuit of… more
- Boehringer Ingelheim (Goldsboro, NC)
- …based. + Performs all Company business in accordance with all regulations (eg, EEO, FDA , DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures. When ... violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.… more
- ITW (Washington, NC)
- …to identify effective solutions for scrap reduction. Compliance/Certification + Maintain the FDA QSR / ISO 13485 - compliant Quality Management System, including ... assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards. + Ensure Management Reviews are conducted to provide for systems review. + Manage Internal Audit Program. New/Change Product/Process Validation +… more