- Legend Biotech USA, Inc. (Raritan, NJ)
- …the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Quality Compliance Manager as part of the Quality team based ... in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance ... Compliance Manager is responsible for regulatory compliance supporting the production of autologous CAR-T products for… more
- Merck & Co. (Durham, NC)
- …Assurance, SFQA, and QO labs (eg, SOPs, logs, CAPAs, QNs). Support technical quality reviews of cGMP documentation for sustained compliance with QMS guidelines. ... Participate in periodic site GEMBAs (walk-downs) as part of on-going Quality and Safety compliance .- Escalate and collaborate quality and compliance … more
- Merck & Co. (Durham, NC)
- …project assignments. Ensure individually assigned aspects of the project proceed in compliance with cGMP, regulations, and our Company's Quality Management ... Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our Company constructed a new manufacturing facility to significantly expand its… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Laboratory Compliance Manager as part of the Quality team based in Raritan, NJ. ... role is an exempt level position with responsibilities for providing quality oversight over the compliance program for the site Quality Control laboratories… more
- Merck & Co. (Durham, NC)
- … Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance .Escalate and collaborate quality and compliance ... all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company's Quality... compliance with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic… more
- Merck & Co. (Rahway, NJ)
- …activities.Communicating, and serving as Quality spokesperson, on a variety of Quality or compliance -related issues. Required Experience :Minimum of 5 years ... Job DescriptionThe incumbent will be responsible for serving as the quality representative for, and providing quality oversight of, contractors performing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … team members to ensure that the organization is in a perpetual state of compliance as follows:Support the Global Quality Lead(s) (GQLs) and Regional Quality ... strategic priorities, by reviewing and monitoring the status of Quality Events (QEs), CAPAs and GCP compliance matters raised to the GQLs and/or RQLs from the… more
- Aequor (Framingham, MA)
- …with manufacturing and support operations to ensure a culture of continuous compliance . Perform batch record review. Perform quality inspections of intermediates ... Research to Quality Control. Interpret complex, explicit documentation to ensure quality standards and compliance . May provide training to new employees.… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Director. Interacts with colleagues within Patient Support Programs, Patient Safety, Quality , NNI IT and Telephony, Medical Information, Compliance , Regulatory, ... Essential Functions Partners with PSS Program Management team to ensure vendor compliance with all quality /safety requirements; educates on process requirements… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …zero defect manufacturing and maintaining strong and efficient conformance to all quality expectations and compliance with all regulatory standards. This ... and prospective customers. Key metrics: Customer Satisfaction, Audit non-conformances, Regulatory Compliance , Cost of Quality , Validation on Time. Job… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …execute and deliver clinical studies/programs on time with a focus on budget, compliance and quality . Leads strong and effective communication to global and ... evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a… more
- Aequor (Libertyville, IL)
- Must have experience with IT Quality & Compliance applications and systems in a bio-tech manufacturing environment.Must have 5&plus years of hands-on experience ... PI). PURPOSE AND SCOPE OF POSITION:The Manufacturing IT Systems Quality & Compliance Specialist - Cell Therapy Manufacturing Systems supports the successful… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … System and by ensuring accountability for the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other ... documents, such as Standard Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and audits by ensuring inspection readiness within facilityProvide oversight for trending of quality compliance metrics Great attention to detail and ability to ... investigation closureMonitor timely completion of batch release related impact assessmentsSupport compliance activities for site Quality Operations in accordance… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …and coach cross functional team staff in areas such as quality , compliance , safety, project planning, process development, technology development.Communicate ... form.PC proficiency using Microsoft Office programs.Ability to design processes that ensure compliance to sound scientific Quality by Design (QbD) principles,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …focused on an EHS first mindset, a Right First Time culture of quality , permanent inspection readiness compliance mindset and passionately drives continuous ... the teamPartner and manage relationships with contractors to ensure quality of work and compliance with all...contractors to ensure quality of work and compliance with all company policies and regulatory guidelinesHelp improve… more
- Merck & Co. (Rahway, NJ)
- … Quality Assurance, the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices ... filings and audits of data, policies, procedures, and systems to ensure compliance with Medical Device (21CFR 820s) and Combination Product current Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …support the QA oversight of Warehouse activities. This position is responsible for quality and maintaining the highest standards in compliance within company ... tasks required to meet business objectives.Support Investigations team by providing quality and compliance input for continuous improvement; and… 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 ... Biotech is seeking QA Lab Oversight Specialist I/II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QA Lab Oversight Specialist role… more
