- Merck & Co. (Rahway, NJ)
- …the role include but are not limited to: Prepare for and support batch processing readiness and execution activities.Prepare, review, and/or approve GMP ... Job DescriptionPosition Description: Senior Specialist , Process Engineer The Small Scale Organics (SSO)...GMP requirements as well as ensuring facility readiness for batch processing. In addition, this position is expected to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking Systems Engineer Specialist as part of the Commissioning and Qualification team based in Raritan, NJ. ... will be responsible in handling day-to-day activities inclusive of project execution and management, vendor management, data management, life cycle management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …consistent resolution and escalation of process issues as applicable, while ensuring batch quality and adherence to procedures and instructions. Support ... in a matrixed environment. Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a CQV Specialist or CQV Associate as part of the Technical Operations team based in ... will be responsible in handling day-to-day activities inclusive of execution , protocol management, vendor management, issues, deviations, corrections and remediation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement programs, reviews completed ... quality records, generates quality deviation responses, drive...manufacturing equipment and processes Revise and create documentation (SOP, batch records, reports) associated with the manufacture of product,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …reflect Boehringer Ingelheim's high regard for our employees. The Principal Specialist , Production Execution Systems assists the supervisor in coordinating ... PES team and between related departments. Using material and batch information in SAP and MES, the incumbent creates...for both the SAP and MES systems. The Principal Specialist , Production Execution Systems ensures that the… more
- Abeona (Cleveland, OH)
- Position Overview The Specialist I, Quality Assurance - Operations performs routine activities associated with manufacturing of cell and gene therapy products at ... of a cGMP Operation for production processes relating to batch record review and release from start to end...procedural and regulatory compliance throughout the manufacturing process. The Specialist , Quality Assurance - Operations will report… more
- Endo International (Rochester, MI)
- …and we are looking for talented individuals to join our team. The Quality Associate Specialist , Product Release, under close supervision, reviews all pertinent ... achieve our mission to develop and deliver life-enhancing products through focused execution . Our nearly 3,000 global team members understand the important role we… more
- ThermoFisher Scientific (Greenville, NC)
- …and continuous improvement initiatives. **Discover Impactful Work:** **This position is Quality Specialist - Computer System Compliance** In partnership with ... career with us. **Location/Division Specific Information** The Computer System Quality Assurance Team provides quality oversight of...and direction for process areas related to electronic master batch release, batch execution , review… more
- Novo Nordisk (Clayton, NC)
- …Automation process during the project. Monitor Automation work package for relevant quality related issues. Ensure compliant execution & monitoring. Drive ... At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For...Batch review Processes required + Good Knowledge of quality management systems required + Good Knowledge of … more
- Curia (Burlington, MA)
- …Specialist I- Burlington, MA Sunday-Wednesday, 7am-5pm or Wednesday-Saturday, 7am-5pm The Quality Assurance Specialist I is responsible for maintaining ... action taken is appropriate and appropriately documented. + Reviews Un-executed /Executed batch records and quality control testing for compliance with internal… more
- Amgen (Holly Springs, NC)
- …associated documentation in support of CSV computer systems validation. + Provide quality guidance and support during execution of commissioning and ... drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies...Quality Systems Compliance team and site in the execution of the site readiness plan with focus on… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a ... documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc. * Accountable...amounts of relevant experience for each level: *Assoc QA Specialist - 2+ years * QA Specialist … more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Quality Assurance Specialist position to support the Manufacturing Execution System (MES). This position will support a ... documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc. + Accountable...of relevant experience for each level: + Associate QA Specialist - 2+ years + QA Specialist … more
- Amgen (Holly Springs, NC)
- …waste, as part of Amgen's plan to be a carbon-neutral company by 2027. ** Quality Assurance Validation & Tech Support Specialist ** **Live** **What you will do** ... drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies...Equipment, and other equipment in the CUB) + Provide quality guidance and support during execution of… more
- ThermoFisher Scientific (Greenville, NC)
- …Shift 12 hrs. Rotation **POSITION SUMMARY** In this position, you'll drive quality execution across the sterile operations including manufacturing, filling, ... support deviation investigations of moderate to high complexity + Performs quality batch record review + Aids in identification of continuous improvement… more
- Catalent Pharma Solutions (Madison, WI)
- ** Specialist I - Quality Assurance, Operations** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the ... network, Catalent Biologics is positioned to drive significant growth for Catalent. The Quality Assurance Specialist is responsible for the quality assurance… more
- Lilly (Concord, NC)
- …environment. This is an opportunity you don't want to miss! Responsibilities: The Quality Assurance Floor Support Specialist is responsible for providing QA ... and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels… more
- Curia (Albuquerque, NM)
- Quality Investigations Specialist in Albuquerque, NM Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology ... industries. The Quality Investigations Specialist is an integral part...resident expert. + Contributes to CURIA's core values of Quality , Timeliness, Communication, and Profitability. + Batch … more
- Bausch Health (Bridgewater, NJ)
- …mission of improving people's lives with our health care products. The **Senior Specialist , External Manufacturing Quality ** plays a crucial role in upholding ... well as standardization across departments. + This position will lead the execution of quality -related activities, including responsibility for measuring and… more