- Legend Biotech USA, Inc. (Raritan, NJ)
- …position with responsibilities for providing quality oversight over the validation and qualification activities for equipment, systems, computer systems, and ... validation , shipping validation , and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation ,… more
- Cipla (Fall River, MA)
- …of qualification and validation documents. Preparation of qualification and validation documents of equipment and computer system. Preparation and ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Manufacturing/Packaging… more
- Syner-G BioPharma Group (Boston, MA)
- …requirements specifications, design & development of process parameters, and the commissioning/ validation of manufacturing processes for compliance with quality ... The Validation Engineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and… more
- Cipla (Hauppauge, NY)
- …working outside of Cipla's US Subsidiaries or Affiliates. Job Title : QA Validation FLSA Classification : Professional, Exempt Work Location : Unit 1, Hauppauge, NY ... vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The...FATs/SATs etc. Perform work to meet company' requirements and quality standards. Represent facility and engineer to communicate with… more
- Formation Bio (New York, NY)
- …processes that ensure Formation Bio and its vendor network comply with GXP, and Computer validation standards. Provide leadership and direction to the quality ... (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for the Vice… more
- Takeda Pharmaceutical (Los Angeles, CA)
- …OOS/OOT rates, and turnaround time. Collaborate with QC, IT, Digital, Validation , Manufacturing, and Quality Systems on LIMS enhancements, integrations, ... to the best of my knowledge. Job Description About the role: Takeda's Los Angeles Quality Control team is seeking a QC Specialist III who will serve as the primary… more
- ValSource, Inc. (Rahway, NJ)
- …Requirements Minimum of 7 years’ experience with increasing responsibility in validation / quality service and project management of life sciences, biotech ... cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11… more
- Christus Health (Santa Fe, NM)
- …a High-Reliability Organization, the QM Coordinator, reporting to the Director of Quality , is responsible for coordinating and acquiring data from source systems ... specific to clinical quality management regulatory and performance improvement metrics using methods...audits, tracers, chronologies, root cause analysis and rounding skill validation activities. The QM Coordinator provides expertise and support… more
- USAA (Plano, TX)
- …We are seeking a skilled individual to execute comprehensive model risk validation oversight for the lifecycle management of models. This includes conducting ... thorough model validation activities and ensuring adherence to written risk and...Conduct and develop plans for model testing and data quality assessments for models using various types of datasets… more
- Insmed Incorporated (NJ)
- …an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will manage ... and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical, biotech,… more
- AUROBINDO (Durham, NC)
- …GxP systems.Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer ... family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition… more
- Merck & Co. (Rahway, NJ)
- …tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position interacts extensively with ... and processes are developed in accordance with applicable regulatory, quality , company, and customer requirements.-This position will lead cross-functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … validation .Assist in the development of process, operational, and quality improvements for manufacturing.Assist in the review and development of process-related ... strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System … more
- Cipla (Fall River, MA)
- …This role will perform IT Systems Support including Systems Implementation, Validation , Administration etc., for Manufacturing, Packaging, Warehouse, Quality ... , PLC. SAP Skills in Production, WH, Packaging and Quality modules Validation , Maintain Infrastructure & Security...of sitting at a desk and working on a computer . Able to be able to wear personal protective… more
- Aptyx (Charlotte, NC)
- …department's objectives to provide goods and services that meet customer requirements for quality , quantity, and timeliness. The primary role of an R&D Engineer is ... to successful conclusions. DUTIES AND RESPONSIBILITIES Responsible for following the Quality system, including all applicable SOPs included in the Training Matrix… more
- Cipla (Fall River, MA)
- …FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management System (QMS) by maintaining accurate, secure, and accessible documentation throughout its ... is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The position reports to the QA QMS Lead and may be matrixed… more
- Cipla (Fall River, MA)
- …to the company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Department Head - Manufacturing ... of approved procedures. Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory… more
- Sanofi (Swiftwater, PA)
- …and providing expertise for process evaluation and product improvements for better quality and yields. The role will provide improved response time to failures ... of automation systems with digital applications to support production, quality control, and data management. Deliverable Accountability: Ensure compliance with… more
- Aptyx (Charlotte, NC)
- Job Description: Quality Inspector I Position: Quality Inspector I Location: Charlotte, NC Department: Quality Reports to: Quality Assurance Supervisor ... can create more good things in the world. We are committed to delivering high- quality products and services to our customers worldwide. We are seeking a talented … more
- Merck & Co. (Durham, NC)
- …The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the ... Maintenance (PM) plans as requested. Responsible for SAP transactions, validation testing support, supporting root cause investigations and change control… more
