- Fujifilm (Holly Springs, NC)
- …regulated environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. **Preferred ... Overview** The QA Engineer, DSM Operations is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing (DSM) processes… more
- Fujifilm (Holly Springs, NC)
- …a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility **Preferred Requirements:** * ... The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides oversight… more
- GRAIL (Raleigh, NC)
- …when applicable. Strict adherence to Standard Operating Procedures, Work Instructions, and Quality Standards in a FDA -regulated facility are mandatory. In ... with other maintenance and technical trades, contractors, engineers, metrology, validation, and quality to help keep these systems operational while adhering to GxP/… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …expertise in SAP BRH & SAP QM module, regulatory compliance (such as GxP and FDA ), and life sciences Quality Management and Batch Release processes. As an SAP ... working closely with cross-functional teams to enhance manufacturing processes, quality management, and overall system integration. **Strategic Solution Architecture… more
- Reckitt (Wilson, NC)
- …productivity. + Compliance & Documentation: Ensure all processes comply with cGMP, FDA , and Reckitt quality standards. Maintain accurate and complete ... in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not...solid dosage (OSD) forms. + Strong understanding of GMP, FDA regulations, and pharmaceutical manufacturing standards. + Hands-on experience… more
- Actalent (Hickory, NC)
- Description Position Summary: The Quality Assurance Analyst is primarily responsible for assisting in maintaining the Quality Management System on a local level. ... includes, but is not limited to, assisting with product quality investigations/corrective and preventative actions, customer complaints, supporting audits,...+ GMP + Data + Compliance + CAPA + FDA + Batch record + Investigation + Root cause… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA , and internal quality standards. This position is in a ... implement continuous improvement opportunities to optimize workflows in the quality control microbiology laboratory. OVERALL JOB RESPONSIBILITIES: Operational Excellence:… more
- US Tech Solutions (Wilson, NC)
- **Job Title: : Quality Documentation Specialist** **Duration: 2 Years contract** **Location : Wilson / NC / 27893** **Job Description:** + This position is ... and direction to all departments in respect of document control to ensure business, quality and compliance goals are met + Partners with other Departments to ensure… more
- Lilly (Concord, NC)
- …safety projects. + Follow all cGMP, and other regulatory requirements. Participate in quality initiatives and audits. Compliance to FDA , EMEA, DEA, OSHA, IDEM, ... a team across various areas. + Solid understanding of quality and corporate policies + Exposure to SAP/EWM preferred....and basic requirements of regulatory agencies such as the FDA , EMEA, OSHA and EPA. + Demonstrated solid judgment… more
- Herbalife (Winston Salem, NC)
- Quality Assurance Engineer I Category: Quality Position Type: Regular Full-Time External ID: 17433 Location: Winston-Salem, NC, United States Date Posted: Aug ... share to linkedin Apply Now **Overview** **THE ROLE:** The Quality Assurance Engineer I will be part of the...Knowledge of Good Manufacturing Practices, Food and Drug Administration ( FDA ) regulations ( FDA 21 CFR - Part… more