- Insight Global (Rochester, MN)
- …to assure accuracy and compliance with GxP , study protocols, and laboratory procedures. * Monitor laboratory quality assurance activities to ... implementation, delegated GxP inspection readiness efforts, providing Quality Assurance Unit support as described in...as assigned. * Reviews and updates Quality Assurance procedures. * Maintains audit forms and QA… more
- ThermoFisher Scientific (Middleton, WI)
- …reports and facility qualification documentation. Conducts internal audits to ensure compliance with established quality assurance processes, standards, ... + This is a support Auditor I role The QA Auditor I assures the quality of...as a resource to operational departments on audit or quality assurance subject matter + Prepares and… more
- Kelly Services (Spring House, PA)
- **Data Auditor ( Quality Assurance )** Kelly Outsourcing & Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is ... currently seeking a Data Auditor ( Quality Assurance ) for a long-term engagement at...and project team members/leaders Maintain the highest level of GxP compliance and evaluate department policies for… more
- ThermoFisher Scientific (Middleton, WI)
- …in one or more specialized areas or processes in the execution of the Quality Management System (QMS). Will attend inter-departmental meetings related to the area of ... expertise and provide input. May serve as a QA client contact for company contracted services and contribute to policy-making decisions as a resource in area(s) of… more
- Cambrex High Point (Durham, NC)
- …the world. Start a career where You Matter by applying today! Job Overview The QA Compliance Manager is responsible for the inspection readiness program for the ... or GMP/GDP audits (for Client, Regulatory & Internal). The QA Compliance Manager works collaboratively with other...experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance . + At least 4 years… more
- WuXi AppTec (Philadelphia, PA)
- …compliance . High level job accountabilities included activities related to sterility assurance , manufacturing oversight, quality system and release of raw ... shift and be on-site. A Specialist role to provide Quality oversight in manufacturing operations at the site and...support manufacturing operations * Stay current with changes to GXP , including FDA and EU and other regulatory bodies… more
- ThermoFisher Scientific (Bend, OR)
- **Job Description** **Job Title:** Quality Assurance Specialist III / Data Integrity Compliance Officer **Last Review Date:** 04Jan2021 **Summary** Supports ... and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards. Performs evaluation of internal… more
- Charles River Laboratories (Mattawan, MI)
- …area + Develop understanding of compliance expectations to respond to quality assurance audit observations in appropriate software with minimal oversight + ... data. Staff are also knowledgeable in the application of GxP 's and applicable SOPs, along with adhering to study...Assist with minimal oversight the completion of laboratory investigations, assay troubleshooting and quality observations… more
- Cambrex High Point (Longmont, CO)
- …+ Good understanding of analytical laboratory practices and able to apply quality assurance principles to the review process to ensure data is scientifically ... small and large molecule development and testing data in compliance with cGMP/cGLP standards and FDA / EU regulations....dates + Escalates issues which may impact timeline to laboratory and quality management + Ensures all… more
- CGI Technologies and Solutions, Inc. (Plymouth Meeting, PA)
- …Working & SDLC Familiarity GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, ... Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Laboratory domain. * Knowledge of Quality & Lab Manufacturing… more
- CGI Technologies and Solutions, Inc. (Plymouth Meeting, PA)
- …& SDLC -Familiarity with GxP Manufacturing Guidelines and/or GxP Quality Control / SCADA, Quality Assurance Experience Lab Equipment, Infrastructure ... -Successful individuals will have significant experience within the Bio-Pharmaceutical Manufacturing Laboratory domain. Knowledge of Quality & Lab Manufacturing… more
- AbbVie (North Chicago, IL)
- …as Pre-Clinical Safety (PCS), Process R&D (PRD), Formulation Sciences (Pharmaceutics), and Quality Assurance ( QA ). Perform. Responsibilities . Mentor and ... appropriate handling of materials, controlled drug and radioactive compounds, and GxP compliance , where applicable. Qualifications Required . Bachelors, Masters,… more
- Sumitomo Pharma (Morrisville, NC)
- … has multiple direct reports and reports to the Operational Vice President, Quality Assurance . **Job Duties and Responsibilities** + Provide Quality ... based and combination product program teams. This role interprets GxP regulations, determines quality requirements, and works...on-going support for the CPC. + Ensure and deliver Quality and Compliance oversight for manufacturing of… more
- Colorado State University (Fort Collins, CO)
- …project record keeping and data compilation/organization + Previous experience working with quality assurance documentation and personnel + Ability to multi-task ... to the success of PSRL and Orthopedic Bioengineering Research Laboratory ( OBRL ) research studies. Quality ...Checks Duty/Responsibility + Daily inspection of data records for GXP compliance requirements. + Contact appropriate staff… more
- Bristol Myers Squibb (Summit, NJ)
- …management systems, mainly Blue Mountain RAM. + Ability to interact effectively with laboratory , QA and Facilities groups. **Basic Requirements:** + BS in ... Commissioning & Qualification Operations** supports the successful operation of laboratory , clinical and commercial manufacturing operations at their home site… more
- Boehringer Ingelheim (Ridgefield, CT)
- …as required and are in compliance with master documents as well as Quality assurance agreement (QAA). + Oversee and manage the external stability program/s ... collaboration with internal and external quality systems. + Monitor contract laboratory activities to ensure compliance and timeliness of certificates of… more
- Colorado State University (Fort Collins, CO)
- …met during cGMP biomanufacturing. Individuals will be working within an FDA compatible Quality System using Quality Assurance approved SOPs, protocols, ... problem solve, and make professional judgments with regard to regulatory compliance , quality and continuous improvement paradigms. The different position… more
- Mayo Clinic (Rochester, MN)
- …performs testing on manufactured products and in-process intermediates to ensure regulatory compliance , integrity, and quality of manufactured products. The VVPL ... CGMP manufacturing operations. Primary responsibilities include meeting product integrity and quality produced for internal and external clients. Scope of the… more
- Bristol Myers Squibb (Bothell, WA)
- …there's no better place than here at BMS with our Cell Therapy team. Our Quality Assurance and Compliance organization is pivotal in upholding quality ... manufacturing, batch release, investigations, customer feedback management, document control, Quality Control testing, and diligent audits. Our team harnesses… more
- AbbVie (Worcester, MA)
- …(Empower) and laboratory management system. + SCADA/DCS an advantage. + Knowledge of Quality Assurance , SLC, Compliance and Data Integrity. + Ability to ... process and business reengineering. + Liaise with Global Enterprise, Infrastructure and Quality system teams ensuring high standards of service delivery and engage… more