- Merck & Co. (Durham, NC)
- …regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm ... drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Manager… more
- Formation Bio (New York, NY)
- … review process, ensuring the effective review and approval of batch records , release testing, and other quality -related documentation. Foster a culture of ... are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you...of quality systems and procedures, including SOPs, batch records , and quality metrics.standard… more
- Aequor (Thousand Oaks, CA)
- …are supporting Rotate every 6 months The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at 's USTO ... training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during… more
- Cipla (Fall River, MA)
- …Hours: Third Shift: 11:00PM - 07:30AM (May vary based on business needs) Reports To : Quality Assurance Manager Salary Range : $21 - $26 PURPOSE The purpose of ... established specifications and standard operating procedures (SOPs). JOB DESCRIPTION The Quality Assurance (QA) Inspector position is an individual contributor… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... (eg, weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions. Ensure cleaning of manufacturing and… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Hauppauge, NY)
- …of rejected material generated during batch process and accountability in the batch record . Review of engineering records (temperature and humidity data, ... follow company policies, safety requirements, cGMP and SOP's. Review of online batch records , area/equipment logbooks, calibration/PMP records etc. Ensure… more
- Cipla (Fall River, MA)
- …Control Room. Receive approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications, training ... Issue the approved and executed documents related to SOPs, batch records , validation and qualification protocols, specifications,...work assigned by Operation Lead, QMS Lead, Head Unit Quality Assurance and Quality Head.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …printed labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems, batch records and SAP.Work in a team based, ... the assigned tasks.Strong proficiency utilizing relevant manufacturing applications (SAP), electronic batch records (EBR), and quality systems.Utilizes tools… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the review and development of process-related protocols and documentation.Provide technical quality oversight for electronic batch records .Support ... compliance with applicable internal standards, industry standards, and global regulations.Provide Quality Oversight for batch records , change controls,… more
- Cipla (Hauppauge, NY)
- …in state of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during ... To dispense the printed packaging materials as per the batch packaging records . Conduct regular inspections of...Experience: At least 2-3 years of experience in a quality assurance role, preferably in the pharmaceutical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell ... is seeking Document Control Specialist as part of the Quality team based in Raritan, NJ.Role OverviewThe QA Document...logbooks.Responsible for storage and archival of GMP documents and batch related records .Perform tasks in a manner… more
- Merck & Co. (Durham, NC)
- …cGMP Guidelines, Collaborative Communications, Corrective Action Management, Electronic Batch Records , GMP Compliance, Healthcare Innovation, Laboratory ... Automations, Process Engineering, Process Optimization, Process Simulation, Product Formulation, Quality Assurance Processes, Quality Operations, Regulatory… more
- Cipla (Fall River, MA)
- …inefficiencies, escalating complex issues when necessary. Ensure proper documentation of batch records , logs, and deviations. Monitor production schedules to ... and CAPAs (Corrective and Preventive Actions). Work closely with Quality Assurance (QA) to ensure adherence to...documents. Knowledge and experience writing, revising, and creating cGMP records and SOP's. Experience with quality system… more
- Eisai, Inc (Exton, PA)
- …during production operations. Perform review and revision of SOPs and master batch record instructions to improve operational accuracy and efficiency.Execute SAP ... CAPA activities. Interact cross-functionally with Upstream/Downstream Operations , Facilities, R&D, Quality Assurance , Quality Control, Validation, and other… more
- Cipla (Hauppauge, NY)
- …data, write final reports and obtain approvals. Review technical documentation such as batch records , SOPs, calibration records , preventive maintenance work ... such as testing, calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... preferred.Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, CQV protocols.Experience with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance.Expertise in GMP compliance ... systems.Experience authoring and executing documentation including but not limited to: Batch Records , SOPs, Work Instructions, protocols.Experience with BAS,… more
- SOFIE (Somerset, KY)
- …and daily dose management reports. * Perform the duties associated with synthesis, quality control, and quality assurance of radiopharmaceuticals, including ... Parts 211 and 212 requirements, by adhering to SOFIE's quality management system and maintain a state of cGMP...and CAPA). * With site QA, review and release batch records as applicable. * With site… more
- Kelly Services (Barceloneta, PR)
- …a job that works for you. How about this one? We're seeking an ** Quality Assurance Specialist ( Batch Record Review)** to work with one of our top global ... finding the job that's just right Maintain custody of batch records and support data audited in...support data audited in the document control area. Facilitate batch record documentation during internal and external… more
