- University of Southern California (Los Angeles, CA)
- cGMP Senior Quality Control (QC) SpecialistApply (https://usc.wd5.myworkdayjobs.com/ExternalUSCCareers/job/Los-Angeles-CA Health-Sciences-Campus/ ... what it is. The Senior QC Specialist at the USC/CHLA cGMP Facility will lead advanced quality control activities to ensure the quality and compliance… more
- University of Southern California (Los Angeles, CA)
- …plans for process and assay development and support the transfer of processes to cGMP manufacturing and quality control . + develops and reviews standard ... and support to effectively carry out projects. + Offers training to manufacturing and quality control teams during the tech transfer process. + Designs and… more
- University of Southern California (Los Angeles, CA)
- …tech transfer of processes) from cGMP manufacturing and assays to quality control . Develops and reviews standard operating procedures (SOP), protocols ... implement and execute projects. Provides training support to the manufacturing and quality control teams during tech transfer. + Designs and produces… more
- Mayo Clinic (Rochester, MN)
- …**Responsibilities** The Mayo Clinic Center for Regenerative Biotherapeutics (CRB) is seeking a Senior Quality Control Engineer with a strong background in ... and cell therapy products (growth promotion, endotoxin, mycoplasma, sterility) performing quality control assays (release, in-process, stability), and supporting… more
- Bristol Myers Squibb (Bothell, WA)
- …careers.bms.com/working-with-us . **PURPOSE AND SCOPE OF POSITION:** The primary focus of the Quality Control Specialist role to support product lot release and ... in-process testing within a cGMP environment. This includes the ability in interface with...and Change Controls. + Train and mentor others on Quality Control test methods and processes. +… more
- AbbVie (Worcester, MA)
- …materials, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control , Training, Regulatory Compliance, ... products while achieving high efficiency. Responsibilities: + Responsible for various aspects of quality assurance and quality control related to products… more
- Endo International (Horsham, PA)
- …system validation) to ensure compliance with cGMP . + Lifecycle management of Quality Control software and equipment. Data Integrity + Identify compliance and ... Summary** The Quality Engineer is a role within the Quality Control organization which oversees Computer System Validation (CSV) activities for all … more
- Cardinal Health (Van Nuys, CA)
- …meet the requirements of 21 CFR 212 ( CGMP ) + Handles and ensures quality of documentation ( control , retention, and archival) to support CGMP activities ... job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on … more
- Catalent Pharma Solutions (Harmans, MD)
- The ** Senior Manager, Quality Assurance Data Integrity Compliance** performs evaluation of internal controls, communications, risk assessments and maintenance of ... cGMP regulations, Catalent standards, and applicable regulatory requirements. + Resolves Quality Assurance issues complex in scope following cGMP regulations… more
- Actalent (West Greenwich, RI)
- …Manufacturing Practices cGMP and other applicable regulations + Ensures that Quality Management Systems comply with cGMP practices and other applicable ... Ensures the Quality unit provides review approval and tracking of cGMP processes procedures assays documents and records including nonconformance's CAPAs change … more
- Pfizer (Rocky Mount, NC)
- …closure of significant investigations and to identify effective CAPAs to resume compliant cGMP activities. The Senior Manager will also provide technical support ... challenges and to support quality functions to maintain compliance with the site cGMP and regulatory requirement, such as FAR, AQRT, eSQRT, etc. The Senior … more
- Cardinal Health (Aurora, CO)
- …job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on ... metrics related products and processes. + Establish and maintain quality control procedures. + Assist in determining...compliance. + Provides ideas for continuous improvement of the cGMP Quality Management System. + Escalates complex… more
- Boehringer Ingelheim (Fremont, CA)
- …recognizing and reporting process and equipment anomalies. + Documents work according to cGMP and cGDP. + Adheres to established regulations and follows cGMP ... operations upon completion of trainer qualification. + Contributes to Quality activities as investigations and area walk-throughs. **Master Associate Requirements**… more
- Actalent (Philadelphia, PA)
- Job Title: Senior Quality Control Specialist, LIMSJob Description The Senior Quality Control Specialist, LIMS role is responsible for the ... with site systems and regulatory requirements working within a cGMP environment. + Manage events, deviations, or QIPs related...due date. + Manage changes and updates through a Quality System (via change control or CAPA).… more
- Actalent (Irvine, CA)
- …and version control of GMP documentation. + Provide assistance during cGMP compliance inspections by regulatory bodies. + Prepare and issue logbooks, effective ... Job Title: Quality Assurance Specialist Job Description + Process GMP...documentation through the electronic document management system ensuring version control , traceable editing, and adequate formatting. + Route documents… more
- Regeneron Pharmaceuticals (Troy, NY)
- We are currently looking to fill a Senior Quality Compliance Specialist, Quality Assurance position on the Quality Assurance Change Control Team. ... oversee operational activities regarding partner change notifications. As a Senior Quality Compliance Specialist, Quality ...be for you if: * Knowledgeable in Biotech/ Pharmaceutical Quality systems inclusive of cGMP , FDA regulations… more
- Bio-Techne (Austin, TX)
- …tools for researchers to further treat and prevent disease worldwide.** The Senior Quality Assurance Specialist will work closely with internal colleagues ... in compliance with all applicable regulations, standards, systems, procedures and practices including Quality System, cGMP , GLP, GCP, CLIA, ISO, FDA, ICH, EU and… more
- Boehringer Ingelheim (Gainesville, GA)
- …and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Specialist, Quality Systems will administer the site's Training ... sessions, and any associated training and learning items. The Senior Specialist, Quality Systems provides guidance on...TrackWise). + Performs trending and analysis of site's Change Control system performance. + Supports Quality Management… more
- Endo International (Horsham, PA)
- … standards in support of cGxP activities. + Assists with all aspects of quality systems, such as Change Control , Deviations, Investigations, and CAPA systems to ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- Takeda Pharmaceuticals (Brooklyn Park, MN)
- …is true to the best of my knowledge. **Job Description** **Job Title** : Quality Control Analyst II **Location** : Brooklyn Park, MN **About the role:** ... and cGMP regulations. + Independently exercise judgment within generally defined Quality Control (QC) practices in selecting methods and techniques to… more