- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Document Control Specialist as part of the Quality team based in ... Raritan, NJ.Role OverviewThe QA Document Control Specialist role is an exempt level position with responsibilities for supporting the document management… more
- Twist BioScience (South San Francisco, CA)
- …Assurance, Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control , Production, Process Development, Product Development, Software Development, R&D, ... and Technical Documents including, but not limited to: SOPs, Design Control Documentation (Design and Development Plan, Customer Requirements, Product Requirements,… more
- Cipla (Central Islip, NY)
- …regulatory requirements. Understanding of regulatory compliance, quality management systems and document control processes, and the ability to collaborate ... analytical techniques (HPLC, GC, UV-Vis etc.) and familiarity with quality control procedures. Responsible for performing routine analytical testing of raw material,… more
- Insmed Incorporated (NJ)
- …You Are:You have a Bachelor's degree along with 2+ years of experience ona document control team using a quality management system, with preference to Veeva.You ... support timely documentation updates and approvals.Lead the implementation of document management processes including evaluation of system workflows, SOP revisions,… more
- AUROBINDO (Durham, NC)
- …reasons.Complete all applicable training forms in a timely manner and forward to document control for archival.Perform other duties as assigned. Qualifications - ... team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture,… more
- Cipla (Fall River, MA)
- …ensure the proper documentation of all quality systems and records. Oversee document control processes, ensuring that SOPs (Standard Operating Procedures), work ... instructions, and other quality documents are up to date and correctly implemented. Assist in the collection, analysis, and reporting of quality data (eg, quality metrics, CAPA (Corrective and Preventive Action) reports, audit findings). Support investigations… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …knowledge and expertise in support of GMP investigations, change controls, document control , process improvement, process validation and data management.Partners ... with Operational Excellence to implement improvements.Writes, reviews, owns and updates SOPs.Owns, provides assessments and takes actions in support of change controls.Owns CAPAs and associated project plans.Supports events such as Root Cause Analysis (RCAs)… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …understanding of regulatory requirements, policies and guidelinesExperience with Quality Control document reviews and regulatory inspection processesWorking ... independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some… more
- Aequor (Thousand Oaks, CA)
- …routine laboratory testing and related activities in support of Quality Control operations. The role requires adherence to current Good Manufacturing Practices ... laboratory procedures and analytical testing in a regulated QC environment Document , calculate, compile, interpret, and enter laboratory data accurately and in… more
- Repligen (Clifton Park, NY)
- …and interpret engineering drawings, specifications, and purchase orders.Accurately document inspection results using Microsoft Office and other software.Use ... in science or relevant experience preferred.Experience in Quality Assurance (QA) or Quality Control (QC) is a plus.Strong attention to detail and ability to work in… more
- Primient (Loudon, TN)
- …drive hardware and other devices designed to integrate with a PLC based control system. Specify and document new instrumentation. Projects and Construction ... that you have read the job specs first. Program, support, trouble shoot and document PLC and HMI processes. Provide programming support to interpret control … more
- Cipla (Hauppauge, NY)
- …support] that management may assign from time to time. Skills: Familiarity with document management systems (eg, Master Control ). Ability to analyze and resolve ... batch documentation issues in a timely and efficient manner . Experience in preparing for regulatory inspections and audits . Excellent organization skills with the ability to focus on details Strong organizational and time-management skills to handle multiple… more
- Insmed Incorporated (NJ)
- …and references.Ensure accurate documentation of reviewer comments, approvals, and version control in the company's document management system (eg, Veeva).Manage ... performance data to identify trends and opportunities for continuous improvement.Oversee quality control and audit readiness, serving as a subject matter expert on… more
- Cipla (Fall River, MA)
- …To : Pkg. Department Head Salary Range : $83,200 - $104,000 Purpose: Control manufacturing activities in the respective section to ensure activities carried out are ... in time. Key Accountabilities Accountability Cluster Major Activities / Tasks Monitor and control planned production by daily activity review as per p packaging plan… more
- Bayer (Muscatine, IA)
- …exchange; Document and complete safety, quality, environmental, and inventory control reports; Conduct equipment isolations and issue work permits to contractors ... equipment. Technicians use knowledge of process and operating procedures to control , monitor, and troubleshoot equipment used to package goods into containers.… more
- Cipla (Fall River, MA)
- …SOP's. In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This ... management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established timelines. Autonomously leads… more
- Cipla (Fall River, MA)
- …execution. In this role the Validation Engineer adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This ... Anticipates risk and builds contingencies to help mitigate impact. Reviews document for accuracy and completeness. Defends the validation programs and strategies… more
- Cipla (Fall River, MA)
- …procedures. Daily monitoring of production performance. Perform manufacturing processes and document activities in batch records and logbooks. Machine operation with ... manufacturing and related documents. Basic understanding of deviation, CAPA, change control , FMECA , OOS,OOT and OOAC. Other Responsibilities Maintaining and… more
- Cipla (Fall River, MA)
- …material with purchase for timely removal from unit by coordinating with unit QA. Control and handle the damaged container as per SOP. Manage the disposal of ... or slow moving items and ensure clearance of items before expiry to control the cost of inventory. Review the non-moving, low shelf life items periodically… more
- Cipla (Central Islip, NY)
- …feedback to the Supervisor on unsafe equipment or working conditions. Effectively document Batch Records and Logbooks. Maintain a safe, clean and organized work ... in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory requirements in… more
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