- Merck & Co. (Durham, NC)
- …or data integrity. Work closely with stakeholders and SME's from site operations, quality operations, IT , automation and engineering to provide evidence of ... risk to accommodate the full scope of work. Provide the independent quality approval of key qualification/ validation documentation such as policies, procedures,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... knowledge for the development/refinement and implementation of the GEP program and validation standards based on risk-based practices as prescribed in ASTM E2500.… more
- Aequor (Bothell, WA)
- …and quality control organizations. This position requires a passion for IT , validation , and compliance. Project management and business analyst skillsets ... OF POSITION:The Benchtop Support specialist position will be responsible for providing IT support in our Digital Plant organization working to support, enhance, and… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... records. Will be a QA presence on the manufacturing floor. Relationships Quality Assurance. Essential Functions Reviews all manufacturing and support records to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Process Improvement, Validation , Supply Chain, Operations, QA, Reg CMC, and IT . This individual will support electronic batch record (EBR) updates and system ... other Supply Chain Systems (ERP, eLIMs, etc.).Coordinate and execute MES validation activities according to the Software Development Lifecycle (eg commissioning test… more
- Verista (Boston, MA)
- …regulations related to FDA / MHRA regulations * Use of computerized quality management systems * Experience with validation of Enterprise / Lab Computerized ... skills and learn from our experiences to enhance our collective expertise Quality Lead Responsibilities: This position will be responsible for supporting the QISM… more
- Teva Pharmaceuticals (West Chester, PA)
- … validation experience in pharmaceutical industry; knowledge in validation and quality compliance (cGMP/cGLP/ICH/ FDA /USP/EU policies/guidelines) ... and/or with subject matter experts to implement process improvements and optimize key validation and quality initiatives * Support internal and external audits… more
- ICU Medical (Austin, TX)
- …and revised validation guidelines, specifications and policies *Interact with Quality , Engineering, Manufacturing, Packaging, IT , and business area users as ... FLSA Status - Exempt *Position Summary * The Validation Engineer I is responsible for process knowledge...& Skills* *Must have knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Knowledge in one of… more
- Kelly Services (Columbus, OH)
- …in the heart of Columbus, OH and 100% onsite. **Job Title:** Quality Assurance Validation Coordinator **Location:** Columbus, OH **Rate:** $35/hr. **Shift:** ... 8am-4:30pm | Mon-Fri **Length of Assignment:** 6 months The Quality Assurance Specialist Validation Coordinator is responsible for managing validations related… more
- Bristol Myers Squibb (Devens, MA)
- …. **PURPOSE AND SCOPE OF POSITION:** The Associate Director, CTF Digital Plant IT Quality at Devens Cell Therapy Facility (CTF) will direct the ... Skills, and Abilities** + Thorough knowledge of regulatory computer system validation requirements including FDA , EMA, and Worldwide Regulatory requirements… more
- HCA Healthcare (Brentwood, TN)
- …(experience preferred by not required)** + System Validation - Understands system validation standards (eg FDA CSV Guidance, Annex 11, GAMP-5, ICH, ISO/IEC, ... for electronic records (eg 21 CFR Part 11). + Quality Management - Facilitates activities between IT ...processes & tools + Preferred- Knowledge of regulatory policies, quality standards, and software validation guidelines (eg… more
- Bristol Myers Squibb (Devens, MA)
- …systems (DeltaV, Syncade, PI, Benchtop IT Systems, etc.) at Devens CTF. + Provides IT quality support to Devens CTF Digital Plant team through quality ... implications or cause significant delays in schedules. + Coordinates with higher level IT Quality personnel on decisions and applies appropriate notification to… more
- Medtronic (San Diego, CA)
- … validation and reliability demonstration activities + Assisting Supplier Quality engineering and purchasing teams in vendor development and component engineering ... **Nice to Have** + Experience working in a regulated industry (eg, FDA -regulated). + Master's Degree in Engineering, Quality , Regulatory, or related.… more
- Allucent (Cary, NC)
- …business decision-making. + Ensure all clinical systems adhere to regulatory requirements (eg, FDA , GCP, ICH), and collaborate on system validation activities as ... optimal system usage and adoption. + Oversee data integrity, validation processes, and reporting needs to support clinical trial...reliability of clinical systems. + Review, improve and evaluate IT processes and procedures within the Quality … more
- Medtronic (Los Angeles, CA)
- …development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations, EU MDR and in-house Standards. + ... involving insulin delivery + Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive… more
- Abbott (Lake Forest, IL)
- …Engineering, and 7 years of related work experience IT or SW Validation is required in quality and regulated environment + International travel: UK, ... highly regulated software development/ validation environment + Hands on with GxP quality systems for IT , Pharmaceutical, or Medical Device industries. +… more
- Medtronic (Los Angeles, CA)
- … operating methods, processes, and procedures (such as ISO13485/IEC62304/HIPAA/ FDA /Security Standards/Data Privacy). + Develops, modifies, applies, and maintains ... and validation . + Defines appropriate measures to ensure product quality . + Develops overall operating criteria to ensure implementation of the software… more
