- Merck (Rahway, NJ)
- … Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global ... computer system validation activities and testing. + Provide independent Quality Assurance oversight for the implementation of new computerized systems,… more
- Cardinal Health (Fort Lauderdale, FL)
- **_What Quality Assurance contributes to Cardinal Health_** Quality develops and implements quality policies, procedures, and processes to ensure ... products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality … more
- Novo Nordisk (Clayton, NC)
- …Has product release authority if role is in batch release. Quality oversight , review & approval of validation activities and documents associated with ... Self Audits (in conjunction with line of business (LoB)); Quality Assurance ( QA ) presence &...Project Management, Validation , laboratory method and equipment validation , warehouse/logistics, and IT preferred + Quality … more
- Bristol Myers Squibb (Indianapolis, IN)
- …Radiopharmaceutical facility in Indianapolis, IN. The Quality Assurance Specialist will be responsible for providing oversight over shop floor activities ... in their personal lives. Read more: careers.bms.com/working-with-us . The Quality Assurance Specialist will help...relationships to improve processes and resolve issues. + Provide quality oversight on manufacturing and validation… more
- Novo Nordisk (Durham, NC)
- …on shop floor. Handles release of raw materials & provides quality oversight , review & approval of validation activities associated with minor changes to ... QA presence & process confirmation on shop floor. Relationships Manager, Quality Assurance . Essential Functions + Ensures site compliance with Regulations,… more
- Novo Nordisk (Clayton, NC)
- …Qualified Person), if role is in batch release. Serve as Quality oversight , review & approval of validation activities associated with projects, new systems, ... confirmation across FP, utilizing LEAN principles. Relationships Senior Manager, Quality Assurance . Essential Functions + Make decisions...Serve as Quality work package owner, or Quality approver of validation documentation + Review… more
- Novo Nordisk (West Lebanon, NH)
- …EMEA or a leading international regulatory agency preferred + As applicable, experience with Quality Assurance oversight and support for all phases of ... procedures + Releases product based on Quality Assurance record review and approval by QA ...signature authority for deviation closure + Reviews and approves Validation Documentation + Reviews and assesses Corrective and Preventive… more
- Novo Nordisk (Clayton, NC)
- …floor & improvement of Quality processes. Relationships Reports to Manager, Quality Assurance . Essential Functions + Ensure that the current Novo Nordisk ... & requirements from health authorities are reflected in the validation planning & quality related decisions +...to root-cause analysis + Participate in process confirmations & quality oversight + Authorized person according to… more
- Novo Nordisk (Clayton, NC)
- …and local standard operating procedures (SOPs)Release of raw materials. Quality oversight , review & approval of validation activities associated with minor ... & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance ( QA ) presence & process confirmation on shop floor… more
- Novo Nordisk (Clayton, NC)
- …and local standard operating procedures (SOPs)Release of raw materials. Quality oversight , review & approval of validation activities associated with minor ... & other documentation. Perform Self Audits (in conjunction with line of business (LoB)), Quality Assurance ( QA ) presence & process confirmation on shop floor… more
- Hovione (East Windsor, NJ)
- …sexual orientation or ethnicity. (https://en-careers-hovione.icims.com/jobs/10062/senior- quality - assurance - specialist ... oversight of activities, as required. - To approve Validation Master Plans, Process Validation Protocols and...have the potential to mitigate unnecessary complexity - Master Quality Assurance processes and tools - Manage… more
- Novo Nordisk (West Lebanon, NH)
- …by the FDA, EMEA or a leading international regulatory agency preferred + Experience with Quality Assurance oversight and support for all phases of Clinical ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...and GMP for all NNUSBPI products. This position has QA signature authority on the review of individual batch… more
- Unither Pharmaceuticals (Rochester, NY)
- …Your role Reporting to the Quality Assurance Manager, The Quality Specialist (Development and Validation ) assists and supports the organization ... Quality Specialist - Development & Validation Who...the Specialist will work directly with customer quality assurance and technical teams. Effective &… more
- Bausch Health (Bridgewater, NJ)
- …our mission of improving people's lives with our health care products. The Quality Specialist provides support for the business' product development portfolio ... who is responsible for the effective management of the quality oversight and delivery of quality...similar field preferred + Prior experience in a GMP quality (Manufacturing/ QA /QC) environment, experience in drug substance,… more
- Quality Consulting Group (Juncos, PR)
- … QA on NPI team. + Lead investigations. + Lead site audits. + Own site quality program procedures. + Designee for QA manager on local CCRB. + Review Risk ... QUALITY CONSULTING GROUP, a leader in the pharmaceutical,...+ Review and approve product MPs. + Approve process validation protocols and reports for manufacturing processes. + Request… more
- Minerva Surgical (Santa Clara, CA)
- …leads a team of Quality Engineer(s), Document Control Specialist (s), and Quality Assurance Specialists. The Sr. QA Manager is responsible for ... in review of manufacturing process and product design changes, validation and risk management activities and ensure that design...QSR . + Manage QA staff, with oversight for quality assurance responsibilities:… more
- ICU Medical (Austin, TX)
- …and utilities as well as Validation documents. The Change Control Plant QA Specialist may also be responsible for daily technical support for change ... be responsible for reviewing and approving Validation documents. . The Plant QA Specialist may be responsible for facilitating the Change Control Review… more
- Lilly (Durham, NC)
- …* Responsible for ensuring training is completed and remains in compliance. Communicates with Quality Specialist Lead and QA Floor Support Supervisor on ... System from the ground up. The Process Technician Quality Assurance Floor Support works as a... Floor Support is responsible for providing support and QA oversight to GMP operations in the… more
- Lilly (Durham, NC)
- …isolator, and visual inspection technology. The Quality Assurance Floor Support Specialist works as a member of the QA Floor Support team and reports ... QA Floor Support Supervisor. Responsibilities include providing QA oversight to GMP operations in the...is completed and remains in compliance. + Communicates with Quality Specialist Lead and QA … more
- ThermoFisher Scientific (New Brunswick, NJ)
- …the Validation Analyst (also referred to as a Scientific Software Compliance Specialist ) will be to provide validation support for local and global regulated ... development of computer systems supporting regulated business processes and computer software assurance . + Follow SOPs and industry standard processes. + Review … more