- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with...preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.GxP Quality System… more
- Insmed Incorporated (San Diego, CA)
- …(Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections ... represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Must… more
- BioAgilytix (San Diego, CA)
- …less than three (3) years' direct hands-on experience with computer systems validationMinimum Preferred Qualifications: SkillsProficiency in Computer System ... The Laboratory Systems Analyst is responsible for providing support to...etc.) Contributes to the development and revision of Computer System Validation procedures and policies (validations, change control, data… more
- Merck & Co. (Durham, NC)
- …lean lab initiatives, have a strong understanding of Laboratory Information Management System (LIMS), handle Quality Notification authoring and provide audit ... ingredient, finished product, and laboratory testing for the BCG vaccine.The Specialist, Quality Control participates in a team of analysts in the development,… more
- Aequor (Thousand Oaks, CA)
- …sampling and inspection of raw materials and components and for performing Quality review of documentation for assigned functions (eg equipment and maintenance ... communication skills Time management Proficient computer skills (ie documentation systems , databases and spreadsheets). Bachelor's degree OR Associate's degree and… more
- Aequor (Thousand Oaks, CA)
- …Engineering areas/staff in the execution of their processes, procedures, and use of quality systems . Duties include purposeful presence on the floor, electronic ... documentation and operations according to company procedures. Experience working with Quality Systems , Strong organizational skills and ability to manage… more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... including audit and inspection management and oversight of the Quality management system . This role is responsible...skills Experience with GxP systems including computer system validation and associated… more
- Aequor (Houston, TX)
- …deviations with the aim at identification of root cause, determining Product Quality Impact (PQI) and implementation of corrective actions to prevent recurrence. ... investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and… more
- Repligen (Waltham, MA)
- …create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality ... of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and supervising direct… more
- Aequor (Thousand Oaks, CA)
- …of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Preferred Qualifications ? Ability to adhere ... to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/data according to company and regulatory guidelines? Ability to organize work, handle multiple priorities and meet deadlines? Strong written and oral… more
- Aequor (Cincinnati, OH)
- Quality Control Analyst I Does the position allow for the worker to be virtual/remote? No Temp to Perm: Temp to perm based on openings and performance Shift ... chemical and dry stock inventory Assist with ordering chemicals/materials COMPLIANCE AND QUALITY Basic knowledge and understanding of USP, cGMP, and FDA regulations… more
- Merck & Co. (Rahway, NJ)
- …investigations, and any related corrective action/preventive action (CAPA).- Facilitate equipment/ system changes, execute periodic reviews and support Quality ... Engineering, Process Design, Process Hazard Analysis (PHA), Process Optimization, Project Management System , Quality Management, Quality Management System… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Merck & Co. (Durham, NC)
- …troubleshooting? We're looking for a dedicated professional to ensure top-notch quality , on-time delivery, and seamless operations in a dynamic GMP manufacturing ... service. Demonstrates ability to meet customer expectations in term of quality /quantity and on-time delivery as appropriate.Oversee and maintain schedule adherence… more
- Repligen (San Diego, CA)
- …by CTI/Repligen includes variable path length UV/Vis spectroscopy instrumentation. The systems are sold primarily into the pharmaceutical and biotech industry and ... of proteins and antibodies in drug discovery and development, manufacturing, and quality assurance. The Laboratory Support Specialist will provide support both at… more
- Aequor (Athens, GA)
- …P&ID's. Assists the team with maintaining an up-to-date working spare parts inventory system for equipment/ systems . Completes all work in accordance with CFRs, ... and Clean Utilities including: plumbing, mechanical, electrical, HVAC, high purity water systems , clean steam, cold storage, fire systems and compressed air.… more
- Twist BioScience (South San Francisco, CA)
- …cGMP, GLP), FDA 21 CFR Part 11, Eudralex Annex 11, and internal quality standards. Oversee and execute comprehensive computer system validation (CSV) activities, ... system validation (CSV) and GxP documentation practices, particularly for custom-built systems .Experience with system integration (eg, ERP, LIMS, QMS) using… more
- Merck & Co. (Rahway, NJ)
- …global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ... set tactical and strategic direction on programs to ensure delivery of high- quality products, test methods, and robust manufacturing processes for both clinical and… more
- Merck & Co. (Rahway, NJ)
- …such as master inventory lists, qualification documentation, calibration documentation, computer system inventories Support internal and external quality audits ... change management and deviation management.Experience supporting internal and external quality audits.Experience in instrument computer system validationTag:… more
- Merck & Co. (Rahway, NJ)
- …a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and ... assigned program(s) . - Works directly in the SAP system to establish a consolidated , visible forecast for...accuracy, and effectiveness of clinical supply planning processes and systems . - Stay updated on industry trends, regulations, and… more
