- West Pharmaceutical Services (Scottsdale, AZ)
- …of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements. + ... on QMS performance to senior management. + Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971. + Adhere to all… more
- NTT DATA North America (Highland Heights, KY)
- … Science, or related discipline. Additional certifications in LIMS administration, Computer System Validation (CSV), GAMP 5, or Quality/Regulatory Compliance ... Documentation & Support Develop and maintain user requirements documentation, SOPs, validation documents, and training materials. Provide hands-on training to lab… more
- Sokol Materials & Services (Skillman, NJ)
- …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
- BeOne Medicines (Pennington, NJ)
- …related scientific discipline and 2+ years of working experience in an FDA -regulated biotechnology, pharmaceutical company are preferred. ** Computer Skills:** + ... material, intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, BeiGene processes and procedures.… more
- J&J Family of Companies (Palm Beach Gardens, FL)
- …Improvement Projects. + Support Design Transfer Activities, including test method validation , process validation , creation of Inspection Plans, measurement ... + Provide Quality Engineering support to manufacturing including audits/assessments, verification/ validation activities, CAPA and nonconformance investigation support, and organizational… more
- Merck (Rahway, NJ)
- …and post-market commercial manufacturing support. BDSC supports stage 1 & 2 process validation deliverables (2011 FDA process validation guidance) including ... to internal and external manufacturing sites, manufacturing investigations, process validation , second generation process development and authoring of regulatory… more
- Abbott (Sylmar, CA)
- …and training to the site engineers for Non-Product Software development and validation , Data Integrity, Cybersecurity, 21 CFR part 11 requirements and ensure ... Engineering in the completion of system/software requirements and other verification and validation processes. + Create and execute or direct software validation … more
- Fujifilm (College Station, TX)
- …technology introduction, equipment selection/qualification, technology transfer, process validation , scale-up, process monitoring, troubleshooting and continuous ... from internal/external manufacturing partners. + Lead, execute and improve the validation program, contamination control strategy, data integrity, etc. for equipment… more
- Kestra Medical Technologies, Inc (Kirkland, WA)
- …the assigned supplier base. Supports supplier selection, supplier process validation /controls, general supplier development. Reviews and approves inspection sampling ... part/assembly qualifications using PFMEA/AQPQ/PPAP techniques + Manages supplier process validation plans, and reports using IQ/OQ/PQ validation techniques… more
- Abbott (Westfield, IN)
- …+ Manages program compliance with Quality requirements (ie Design Control, Process validation etc.). + Can identify work environment issues (ie OSHA regulations, ... (DOEs). + Assists in start up of new equipment and execution of validation protocols. + Participates in technical design reviews for process equipment and product… more