- Integra LifeSciences (Princeton, NJ)
- …and ISO (ISO 13485) standards is required + Knowledge of 21 CFR Part 11 and Computer / Quality System Software validation is required + Strong oral and written ... and Training team and is the Enterprise Compliance Master Plan (ECMP) Quality Management System (QMS) team leader with responsibility to design, implement and… more
- Insight Global (San Francisco, CA)
- …ensure systems are validated and maintained in their validated state. * Maintain computer system inventory * Ensure validation documentation are retained per the ... ISO 13485, ISO 14971 o GAMP5 guidelines, FDA guidance on risk-based software validation and computer software assurance * Proven Experience with software… more
- Terumo Neuro (Aliso Viejo, CA)
- **12874BR** **Title:** Staff Engineer, Quality (New Products) **Job Description:** Production Support Focus Lead quality engineering projects to support the ... Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improvements. Product… more
- Bristol Myers Squibb (Devens, MA)
- …Cell Therapy Facility (CTF) in Devens, MA will be responsible for providing Quality oversight of qualification and validation activities and change control for ... operations of the Devens Cell Therapy Facility, including commissioning, qualification, and validation (CQV), computer systems validation (CSV) and process… more
- CACI International (Crane, IN)
- Entry Level Computer Engineer Job Category: Engineering Time Type: Full time Minimum Clearance Required to Start: Secret Employee Type: Regular Percentage of Travel ... the job and what is appealing about the opportunity) CACI is seeking a Junior Computer Programmer to support our customer at NSWC Crane. You will be responsible for… more
- Lilly (Pleasant Prairie, WI)
- …and QA oversight for change management, QRM, process validation and equipment validation efforts. + Works with the site quality to support the development ... part of the site Utilities Process Team and Business Quality Assurance for local computer systems. **Basic...GMP production environments. + Previous experience with C&Q and Validation oversight including automation and computer systems… more
- Medtronic (Jacksonville, FL)
- …supplier quality to ensure that materials and components meet regulatory and quality standards. + Test Method Validation - Lead the planning and execution ... may be assigned. + Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially...R&D on the identification of challenge samples. + Process Validation - Lead the planning and execution of process… more
- Quality Consulting Group (Juncos, PR)
- …and validation . + Defines appropriate measures to ensure product quality . + Develops overall operating criteria to ensure implementation of the software ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...skills + Technical writing knowledge + Knowledge of Process validation and Computer software validation … more
- Candela Corporation (Marlborough, MA)
- …position you will have direct accountability for DQA, SQA, Test Method Validation (TMV), Computer System/Software (non-product) Validation (CSV), ... **Director, Design and Supplier Quality ** Requisition Number **2882** Location **US - Marlborough,...for NPI Design Controls, Design Transfer, and the successful validation /maintenance/improvements linked to both CMO production and other supplied… more
- West Pharmaceutical Services (Exton, PA)
- …guidance on regulatory and industry standards concerning data integrity, including computer system validation , audit trails, electronic signatures, and data ... Principal, Quality Assurance, GMP Requisition ID: 70962 Date: Oct...and industry expectations in terms of data integrity requirements: computer system validation , audit trail, electronic signature,… more
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