- Merck & Co. (Rahway, NJ)
- …findings during documentation reviews. Collect, prepare and analyze data to support quality system metrics and planning. Support compliance activities ... API, is responsible for independent review and approval of documentation to support Good Manufacturing Practice (GMP)...include but are not limited to the following: Perform quality assurance activities related to API (including… more
- Merck & Co. (Rahway, NJ)
- …worldwide regulations and requirements. This position provides Device quality engineering, quality assurance support and leadership to ensure successful ... , the Associate Director Quality Engineering & Quality Assurance is responsible for independent compliance support of Medical Devices including… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Position This position is responsible for performing reviews of manufacturing and support documentation and records to certify compliance with in-house ... individual batch records, supporting test records and other ancillary support records. Will be a QA presence on the...audits of NNUSBPI Manufacturing facilities Releases product based on Quality Assurance record review and approval by… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …be a QA presence on the manufacturing floor. Relationships Quality Assurance . Essential Functions Reviews all manufacturing and support records to certify ... FDA, EMEA or a leading international regulatory agency preferred As applicable, experience with Quality Assurance oversight and support for all phases of… more
- Novo Nordisk Inc. (Durham, NC)
- …compliance with Regulations, ISO standards, corporate & local SOPs Reviews & approves documentation for Quality approval - batch records & other documentation ... review & approval of Change Requests (CR's) & other documentation (in conjunction with LoB). Performs archiving duties and...Quality Management Systems (QMS) preferred General knowledge of quality oversight & on floor production support … more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …execution of applicable documentation for Cleanroom Qualification activities.Provide quality support for Airflow Visualization StudiesParticipate as needed ... is expected to coordinate project execution and to work alongside Sterility Assurance , Quality , and Operations personnel to ensure execution. The primary… more
- Aequor (Thousand Oaks, CA)
- …Quality (PQ) Quality Assurance (QA) Specialist, you will actively provide quality assurance support to the PQ organization as a subject matter ... assurance responsibilities while owning, reviewing, and/or approving Product Quality records and documentation including: product specifications, in-process… more
- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. - The Quality Assurance Specialist will support this expansion. Project ... Job DescriptionPosition Description: Specialist, Quality Assurance 1st Shift - Our...support in the execution and review of GMP documentation such as IQ, OQ and other technical documents… more
- Tris Pharma (Monmouth Junction, NJ)
- …Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team ... and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation , compliance efforts, quality … more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump start… more
- Aequor (Chattanooga, TN)
- …Direct Report to: Sr Manager, Quality Dotted Line to: N/A Department: Quality Assurance Location: Chattanooga, TN Job Summary This contract position is ... responsible for various aspects of support for the Stability program including the organization of...duties as assigned (eg - lab clean up) Interfaces Quality Assurance Quality Control (Analytical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …site improvement projects and strategies.Be a Subject Matter Expert on quality assurance topics within the group in support of QC lab activities.Detailed ... candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , or cell… more
- AUROBINDO (Durham, NC)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control, and regulatory affairs. In ... history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization have given Aurolife a jump start… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …System (EDMS) while collaborating with the Engineering team to provide necessary documentation , quality system interaction, and performing a variety of highly ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...This role requires prior CAD experience as they will support the CAD Specialist with CAD drawings as needed.… 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 ... usageManage the periodic review process for proceduresIssuance of batch related documentation in support of GMP manufacturingReconcile GMP documentation… more
- Twist BioScience (South San Francisco, CA)
- …quality into product design, and work closely with development and software quality assurance teams on product and process improvements.Develop and manage ... test plans to ensure the quality of laboratory software releases.Write documentation for... for business certifications.Train users to leverage new software features. Support Software UsersWork with teams to define post-release software… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , quality control, manufacturing compliance, clinical ... providing quality oversight over the compliance program for the site Quality Control laboratories in support of both clinical and commercial manufacturing.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing complianceKnowledge of cGMP regulations and ... setting with Quality , Manufacturing Operations, Facilities & Engineering Quality Control, Operations Technical Support , Supply Chain and… more
- AUROBINDO (Dayton, OH)
- …family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In ... history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining our facilities and assuring the integrity and ... potential with us? The Position The purpose of this position is to support analytical input into the development and implementation of a worldclass pricing strategy.… more
