- Insmed Incorporated (San Diego, CA)
- …Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director, Quality Assurance - Analytical, GMP has responsibility for the QA ... oversight of Insmed Gene Therapy (GTx) analytical laboratories, review and approval of GMP analytical records. Will also provide QA support for GTx Quality … more
- Merck & Co. (Durham, NC)
- …to lift 25 lbs. Preferred Experience and Skills: Prior experience in a GMP Quality Control laboratory strongly preferred Cell culturemaintenance and aseptic ... Job DescriptionJob DescriptionOur Quality Assurance group ensures every single material inside...and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …procedures to ensure adherence to the implementation of global and harmonized Quality Standards and regulatory requirements for GMP area. Responsible for ... and investigational purposes, drug substances, intermediates and service providers provide GMP compliant activities ensuring the stable and quality supply… more
- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... lunch) Lab Based Bachelor's degree. Nice to have: documentation practices, GMP , previous lab experience.Responsibilities: 1) Receive, clean, and evaluate product… more
- Merck & Co. (Rahway, NJ)
- …the Rahway based clinical equipment, systems and facilities in accordance with GMP and Safety requirements, as well as exercising Reliability Maintenance best ... and mentoring of engineers within the group. Provide engineering and quality engineering (QE) support, ensuring facilities, utilities and equipment are maintained… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …justified.Advise end-users on documentation mechanisms to ensure adequate compliance to GMP .Leads or contributes to Quality process improvement initiatives, ... master documentation. This position will additionally serve as a final Quality Reviewer/Approver for internal documentation. The Documentation Control Supervisor is… more
- Merck & Co. (Rahway, NJ)
- …to processing, ensuring that the labs and equipment in the facility are ready for the GMP and non- GMP work that the scientists need to perform, working with the ... compliance representatives, safety partners and other team members to ensure the quality and safe delivery of clinical supplies, and ultimately to enable flexibility… more
- Merck & Co. (Durham, NC)
- …Vaccines Manufacturing and Bulk Facilities (B101, B102, B130, B150 and B160), Quality Labs, Maintenance and Material Storage Facility (MMSF) and Teknika Facilities. ... schedule including all maintenance, calibration, capital project work, and GMP Cleaning for supported department(s)Coordinates with maintenance schedulerSupport departmental… more
- Insmed Incorporated (San Diego, CA)
- …fast paced, collaborative, and multidisciplinary team. This individual will join the Quality Control leadership team. As the QC Stability and Sample Management ... for the QC stability and sample management operations in support of routine GMP operations at Insmed Gene Therapy. The ideal candidate will have commercial … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director of Quality Project Management and Strategyas part of the Quality team based ... in Raritan, NJ. Role OverviewThe Associate Director of Quality Project Management and Strategy role is an exempt...support both clinical and commercial requirements in a sterile GMP environment. This role will oversee, lead and support… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, ... and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing… more
- Aequor (West Greenwich, RI)
- …11 months duration with possible extension. Ideal candidate: Understands the importance of GMP and the why behind a regulated industry. Recent bachelors but with ... position will perform routine procedures to support testing within Quality Control. Tasks may include but not limited to...and laboratory notebooks. Skills: some lab experience is preferred. no academic research experience, would like a GMP lap… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …documentation and records to certify compliance with in-house specifications/standards and GMP for all NNUSBPI products. This position has QA signature authority ... certify compliance with specifications and procedures Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, walk… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …myeloma.Legend Biotech is seeking QA Document Control Specialist as part of the Quality team based in Raritan, NJ. Role OverviewThe Quality Assurance Document ... facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …facility is appropriately purchased, qualified, deployed and maintained following necessary GMP requirements. This person will be the lead for equipment ... preventing failures (increasing availability), but also on increasing EHS & QUALITY compliance or reducing costs (without reducing availability). He/she monitors the… more
- Aequor (West Greenwich, RI)
- …PM Job Details: In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires ... bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. Responsibilities Include the Following: Provide… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …cleaners to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1st shift ... shift cleaning team to ensure facility readiness for manufacturing operations and quality control labs next shift.Communicate with all key stakeholders (MFG, FAC,… more
- Merck & Co. (Durham, NC)
- …and stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance, employee and environmental ... for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking QA Document Control Leadas part of the Quality team based in Raritan, NJ. Role OverviewThe QA Document Control Lead role ... facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the document management system,… more
