- BioAgilytix (Durham, NC)
- …then you'll be right at home here at BioAgilytix.Essential ResponsibilitiesPerforms Quality Assurance ( QA ) audits, inspections (internal/external), and ... patients who need them.In this role, you will champion quality and compliance in our solutions. Our...Not less than two (2) years' experience in GLP/GCLP quality assurance ( QA )Experience working in… more
- FUJIFILM Holdings America Corporation (College Station, TX)
- …and approve data / reports during release & stability testing. Ensures laboratory compliance to established specifications and procedures. Reports excursion/out ... Assure the implementation of appropriate and timely corrective actions.Work closely with Quality Assurance and other departments to continuously improve the… more
- On-Board Companies (Summit, NJ)
- …may impact timely completion Knowledge of FDA / EU / PDMA / IGJ, GxP environments, ISO, and associated compliance regulations Adept in Microsoft Office Suite ... & Reliability Engineer will also support the successful operation of facility, laboratory , and business functions at multi-use GMP sites within Client, Summit West… 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
- IQVIA (Durham, NC)
- … issues to QA management according to required timelines. + Advising quality assurance management on system audit needs. + Assisting in hosting customer ... Knowledge of word-processing, spreadsheet, and database applications. + Considerable knowledge of GXP regulations and quality assurance auditing techniques.… more
- IQVIA (Indianapolis, IN)
- …+ Presenting educational programs and providing guidance to operational staff on compliance procedures. + Providing quality assurance consultancy activities ... preferred. + 3 years' experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience. + Knowledge of… 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
- 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
- ThermoFisher Scientific (Wilmington, NC)
- …you will lead complex, multi-department internal and/or external audits to ensure compliance with established quality assurance processes, standards, global ... and prioritize complex demands/workload + individuals with prior experience in Clinical Quality Assurance / Compliance - GCP audit, inspection, consultancy… 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
- Randstad US (Marietta, PA)
- …may be required. Preferred: - Some experience in analytical systems including quality control, validation, documentation and compliance preferred. - Strong ... materials such as cartons, syringes, glass vials, tubing, etc. Perform routine laboratory tasks such as safety shower and eye-wash testing, glass-ware cleaning and… more
- J&J Family of Companies (Raritan, NJ)
- …experience with software testing, quality assurance ( QA ), and compliance requirements. such as FDA, GxP , and 21 CFR Part 11/Annex 11. within ... Johnson is recruiting a **Technical Product Owner** to support Quality , Compliance , and Labs (QCL) technology functions...supporting tools like Jira and Confluence. + Proficient with Laboratory Systems (ie LIMS, SDMS, etc.) and/or Quality… 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
- Grifols Shared Services North America, Inc (Clayton, NC)
- … professional organization, eg ASQ CQA is highly preferred. + 8 years of extensive quality assurance / quality compliance experience working in a domestic ... and regions. **Job Overwiew:** Responsible for managing all aspects (ie quality systems, documentation, laboratory operations, compliance , training,… 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 (Bothell, WA)
- …to ensure continued compliance and performance. + Foster a culture of compliance , quality , and continuous improvement within the validation team. + Interface ... heavily involve the use and management of validation document control and quality system software and applications (eg ValGenesis, Infinity, Veeva Vault, Success… 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 (North Chicago, IL)
- …Quality Assurance /Regulatory Affairs, pharmaceutical/device/healthcare industry, compliance /auditing experience (preferred) and/or laboratory experience ... Research & Development. Provides leadership, direction, and execution in compliance and quality ; ensures that activities are...standards (eg MDR, IVDR, ISO, FDA, etc.). Understanding of GxP (GMP, GLP, GCP, GDP, GCLP) preferred. + Must… more
