- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Rahway based Senior Specialist, Global Development Quality Operations , is responsible for independent approval of documentation to support GMP ... or related industryExperience in one or more functional areas such as quality control, quality assurance , analytical laboratories, manufacturing, production… more
- Formation Bio (New York, NY)
- …efficiently.About the PositionWe are seeking a highly accomplished, strategic Vice President of Quality Assurance . In this pivotal role, you will have the ... to establish the strategic development and operational management of Formation Bio's quality assurance program to support the growing drug development… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... degree (MS, PhD, PharmD) strongly preferred.Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... candidate has experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 -...and associated controls during the batch run. Act as quality lead for all shop floor questions… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Associate Director, Patient Services Quality & Process leads quality assurance and process improvement ... patient services programs. This role serves as the primary liaison for quality operations , ensuring compliance, consistency, and operational excellence across… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … and complaint product supply.Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- Insmed Incorporated (NJ)
- …all stages of product development, including Research, Preclinical, Clinical, Regulatory, Operations , Quality Assurance .Innovative thinking and an ... engaged and aligned with project goals including Manufacturing, Analytical Development, Quality Assurance , and Regulatory, with input from Commercial, Research,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overnight travel. Qualifications Bachelor's degree in a relevant field (Life Sciences, Quality Assurance , Regulatory Affairs, etc.); advanced degree preferred 7+ ... the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, &...years of experience in documentation management, quality assurance , or regulatory compliance within the… more
- Merck & Co. (Rahway, NJ)
- …regulatory standards (eg, FDA, cGMP), maintain optimal environmental conditions for product quality , and support continuous operations . The ideal candidate will ... for leading and developing a team that supports HVAC operations and system infrastructure at the Rahway (RY) NJ...ensure compliance with GxP (as applicable) and other regulatory requirements. Lead the operation of the site BAS and HVAC… more
- Cipla (Fall River, MA)
- …implement procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA). Check and monitor for cleanliness, maintenance, ... procedures, and criteria to increase the efficiency of plant operations .The job duties for this position include but are...Minimum of two to three (2-3) years' experience in quality assurance in a cGMP pharmaceutical manufacturing… more
- Cipla (Central Islip, NY)
- …Work closely with internal stakeholders, including global procurement, R&D, manufacturing, quality assurance , supply planning and finance teams, to understand ... of materials, services, and capital expenditures necessary for pharmaceutical operations across multiple manufacturing sites and Contract Manufacturing Organizations… more
- Eisai, Inc (Exton, PA)
- …in root-cause analysis and CAPA activities. Interact cross-functionally with Upstream/Downstream Operations , Facilities, R&D, Quality Assurance , ... Biologics Operations .Self-starter with a strong focus on detail, safety, quality and results. Demonstrates grit and persistence in overcoming obstacles. Strong… more
- Cipla (Fall River, MA)
- …Follow procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA). Check and monitor for cleanliness, maintenance, upkeep ... to other operational functions to include but not limited to Packaging Operations , Manufacturing Operations , and Warehouse Operations . Job Description… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs ... Management Process for the respective business areas.Responsibilities:Leadership and Project Management: Lead the end-to-end quality execution across Medical… more
- Cipla (Fall River, MA)
- …Move materials from Quarantine to Released or Rejected areas as directed by Quality Assurance . Perform dispensing activities for Packaging and Raw materials ... Purpose : The purpose of this role is to assist in the warehouse operations of a pharmaceutical manufacturing company. Multifunctional Role : This job is a… more
- Cipla (Fall River, MA)
- …deviations, non-conformances, and CAPAs (Corrective and Preventive Actions). Work closely with Quality Assurance (QA) to ensure adherence to standard operating ... Monitor packaging processes for adherence to cGMP, FDA, and Cipla's quality standards. Identify and resolve operational inefficiencies, escalating complex issues… more
- Novo Nordisk Inc. (Boulder, CO)
- …to our patients Work effectively across all departments, such as Quality Assurance / Control, Chemical Development, Program Management, Regulatory, Analytical ... merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both...in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage… more
- Insmed Incorporated (San Diego, CA)
- …clinical development and operations , regulatory, medical affairs, drug safety, and quality assurance teams, as well as overall program support ensuring ... you will support and work predominately with the Clinical Trial/Indication Lead (s) and Medical Monitor(s) for assigned protocols and/or projects, partnering with… more
- Sartorius (Yauco, PR)
- This role will be responsible of support the quality technical aspects and activities for Cell Culture Media Operations . The holder of this position will support ... the implementation of quality initiatives and continuous...process characterization, cleaning validation, QC method transfers and other manufacturing/ operations activities. Responsible for projects execution and implementation and… more
