- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a Quality Systems Lead as part of the Quality team based in ... Raritan, NJ. Role OverviewThe Quality Systems Lead role is an exempt level position with...preferably in quality assurance, manufacturing compliance, clinical quality , or cell therapy.GxP Quality System… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Director of Manufacturing Execution System as part of the Global MSAT team based in Raritan, NJ. Role ... OverviewThe Director of Manufacturing Execution System (MES) will be part of Manufacturing Science and Technology (MSAT) Leadership Team and will be responsible for… more
- Merck & Co. (Rahway, NJ)
- …Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence (COE) is responsible and accountable for ... molecule bulk and primary packaging components and packaging master data and systems .The Packaging Technical Operations organization aims to be an industry leader in… more
- Eisai, Inc (Nutley, NJ)
- …strategy including audit and inspection management, issue management and oversight of the Quality management system . This role is responsible for Good Clinical ... (including audit and inspection management, issue management, and oversight of the quality management system ).Conduct complex audits of sites, vendors and… more
- Merck & Co. (Rahway, NJ)
- …research including at least 2 years with developing and managing clinical quality systems and management of regulatory inspections.Profound knowledge and ... with other pharmaceutical companies).Ensuring that essential elements of the quality management system are in place for...clinical development programs, clinical trial processes as well as quality management systems and quality … more
- Eisai, Inc (Nutley, NJ)
- …out routine, complex and for-cause audits Knowledge of data integrity controls and systems quality for clinical area Strong analytical skills and report writing ... including audit and inspection management and oversight of the Quality management system . This role is responsible...skills Experience with GxP systems including computer system validation and associated… more
- Insmed Incorporated (San Diego, CA)
- …(Essential Role Responsibilities):Establish and maintain a risk-based and scientific-based quality system to support GCP.Oversee regulatory agency inspections ... represented in current SOPs is essential.Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice.Must… more
- Merck & Co. (Millsboro, DE)
- … Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management, Quality Management Systems (QMS), Quality ... Job DescriptionThe Quality Assurance Director will provide compliance leadership and...substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any… more
- Repligen (Waltham, MA)
- …create and revise procedures, practices, and specifications; provide training on quality system and procedures.Maintain strong cross-functional quality ... of experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years of experience mentoring and supervising direct… more
- Repligen (Waltham, MA)
- …analysis and corrective action methodologies. Proficiency in conducting risk assessments and quality audits. Experience with eQMS systems or digital audit tools ... OverviewWe are seeking a Supplier Quality Engineer to join our growing Supplier Quality team. You will a key role in ensuring the quality , compliance, and… more
- Aequor (Irvine, CA)
- …R&D, Supply Chain, Finance, etc.). Ensure compliance with the company's Quality System policies and procedures and applicable external requirements ... are implemented to address the root cause of trending issues. Supports quality functions pertaining to manufacturing line support and maintenance, including SAP.… more
- Aequor (Thousand Oaks, CA)
- …weekend (1x/ month this is a rotation)The ideal candidate for this MCS Associate, Quality Control role will hold a bachelor's degree in Biology, Microbiology, or a ... computing, compiling, interpreting, and entering data in Laboratory Information Management Systems - Maintaining and operating specialized equipment - Must learn and… more
- Aequor (Thousand Oaks, CA)
- …collaborative attitude to the team. Comfortable with basic computer skills and documentation systems . Familiarity with GMP principles is a plus, but not a strict ... of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Preferred Qualifications: Ability to adhere… more
- Aequor (West Greenwich, RI)
- …Generate complete, accurate, and concise laboratory documentation using electronic systems and laboratory notebooks. 4. Operate and maintain specialized laboratory ... equipment and instrumentation. 5. Participate in laboratory investigations and audits as necessary. 6. Perform general laboratory housekeeping activities. 7. Maintain training compliance and proficiency. 8. At all times, comply with safety guidelines,… more
- Aequor (Thousand Oaks, CA)
- …of training records, laboratory documentation, written procedures, building monitoring systems and laboratory logbooks. Preferred Qualifications ? Ability to adhere ... to regulatory requirements, written procedures and safety guidelines? Ability to evaluate documentation/data according to company and regulatory guidelines? Ability to organize work, handle multiple priorities and meet deadlines? Strong written and oral… more
- Merck & Co. (Durham, NC)
- …training to mechanics and other maintenance personnel.Interface with safety, production, and quality groups to ensure facility operations and systems comply with ... site includes an Energy Center, Vaccines DP and DS Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... process validation, shipping validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation,… more
- Merck & Co. (Durham, NC)
- …steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System ... The site includes clean utilities, facilities equipment, manufacturing production equipment, quality labs and a warehouse. The candidate will support the… more
- Insmed Incorporated (San Diego, CA)
- …This role will be responsible for the development and implementation of EDC systems to support clinical trials, ensuring data quality , compliance, and efficiency ... solutions comply with GCP, 21 CFR Part 11, and CDISC ODM StandardsData Quality & Compliance:Ensure EDC systems comply with regulatory requirements (eg, FDA,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …requirements. This person will be the lead for equipment optimizations as well as system upgrades with the systems engineering team. This role will require ... (Corrective and Preventive Actions) and CCs (Change Controls) within quality management systems . You will also write...and work instructions that are part of the QMS ( Quality Management System ).You combine the knowledge of… more
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