- Novo Nordisk Inc. (Durham, NC)
- …in Regulations & quality systems (eg, commercial product disposition, DV/ CAPA , Change Control, Audits, Supplier Management, Project Management, Validation, etc.) ... required Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred Experience with Risk Assessment & Vendor Assessments required Minimum of four (4) years of experience in reviewing GMP documents for… more
- Fujifilm (College Station, TX)
- **Position Overview** The Senior QC Deviation Investigator/ CAPA Specialist is responsible for leading deviation investigations to ensure accurate, thorough, ... various roles related to investigations as required. + Provide metrics to Senior Leadership. + Ensures required management and Quality approvals on final… more
- Fujifilm (College Station, TX)
- **Position Overview** The QC Investigator/ CAPA Specialist is responsible for supporting deviation investigations to ensure accurate, thorough, and on time ... while satisfying established due dates. Facilitates corrective and preventive action ( CAPA ) agreement with stakeholders. + New Business Growth + Support client… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The ** Senior Specialist , QC Materials Management** is responsible for the management of materials ... and other departments for the management of QC materials. The QC Material Management Senior Specialist will also serve as the QC Material Management SME,… more
- Kelly Services (Sunnyvale, CA)
- …$47-50/ hour. **Company:** Kelly(R) Science & Clinical **Overview** The Regulatory Affairs Senior Specialist , NPD is responsible for evaluating and ensuring ... realm. **Workplace:** Onsite in Sunnyvale, CA or Remote US **Position Title:** Senior Regulatory Affairs Specialist , New Product Development **Position Type:**… more
- Medtronic (Northridge, CA)
- …will close on - 24 Jun 2025 **Position Description:** Sr. MDR/Vigilance Specialist for Medtronic, Inc., located in Northridge, CA. Responsible for monitoring all ... 803 & 806, ISO-13485, ISO-14971 and ISO 9001. Support and coordinate CAPA (Corrective and Preventive Action) planning and implementation. Responsible for determining… more
- Medtronic (Minneapolis, MN)
- …first through ensuring compliance in everything we do. In this role as a Senior Quality Systems Specialist , you will ensure compliance with Medtronic policies, ... requirements. You also will provide guidance and mentorship on CAPA processes and tools, such as root cause analysis,...EU MDR, and FDA CFR preferred + Experience with CAPA and Root Cause Analysis tools + Ability to… more
- Fujifilm (College Station, TX)
- **Position Overview** The Senior Compliance Specialist owns all manufacturing CAPAs, change controls and deviations. Leading all manufacturing deviation ... including the underlying rational of those principles. **Compliance** + Lead deviation, CAPA , and change control closure for Manufacturing + Leads review of quality… more
- Bayer (Berkeley, CA)
- …and diverse minds to make a real difference, there's only one choice.** ** Senior Specialist , Conformance** **PURPOSE:** TheSenior Specialist , Conformance is ... TASKS AND RESPONSIBILITIES** The primary responsibilities of this roleSenior Specialist , Conformance: + Investigate complex and Critical-level discrepancies using… more
- IQVIA (Durham, NC)
- We are seeking a ** Senior Metrology Specialist ** to join IQVIA Laboratories in **Durham, NC** . We hire passionate innovators who drive healthcare forward ... we transform and accelerate research and development. As a Senior Metrology Specialist , you will ensure laboratory...a subject matter expert during audits and inspections, supporting CAPA and quality initiatives. + Mentor junior staff and… more
- Curia (Rensselaer, NY)
- Senior Quality Assurance Validation Specialist in Rensselaer, NY Build your future at Curia, where our work has the power to save lives! Curia is a global ... contributions + Learning platform + And more! Summary The Senior Quality Assurance Validation Specialist assists with...process or equipment and monitor the successful completion of CAPA and the effectiveness check if needed + Review… more
- Bayer (Berkeley, CA)
- …and diverse minds to make a real difference, there's only one choice.** ** Senior Validation Specialist , Quality Control** We are seeking a dedicated and ... highly skilled Validation Specialist to join our Quality Control (QC) organization. The...change control, deviation investigations, and Corrective and Preventive Actions ( CAPA ) to ensure compliance. + Perform instrument qualification, computer… more
- Eurofins (Sanford, NC)
- …Provide final QA approval on simple change control, effectiveness check, CAPA implementations, compendial assessments, and other documents associated with the ... Controls, Stability Protocols, and all the implementation activities. Support in CAPA closures, Effectiveness checks, and experience in Root Cause Analysis tools.… more
- GE HealthCare (Aurora, OH)
- …standards and regulatory requirements are addressed. + Ensures quality of CAPA (Corrective and Preventive Action) projects, including robust root cause ... and Validation, Production and Process Controls, Corrective & Preventive Action ( CAPA ), and Risk Management across functions. + Demonstrated ability to collaborate… more
- Cambrex High Point (Longmont, CO)
- …around the world. Start a career where You Matter by applying today! Job Overview The Senior QA Specialist I is an expert in their assigned area and has a ... procedures and practices to determine appropriate action (root cause analysis tools, CAPA , etc.) for quality events. * Good interpersonal skills and willing to… more
- Integra LifeSciences (Princeton, NJ)
- …of care. As part of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional with complete and in-depth conceptual ... recommendation on Trackwise functionalities to cover the Quality processes ( CAPA , Audit, Complaint, Supplier Quality Management, Non-Conformance ) and contributes… more
- Charles River Laboratories (Northridge, CA)
- …including deviations, change control, corrective and preventive actions ( CAPA ), exceptions, customer complaints, and post-donation information. Notify management ... and departments for any issues impacting SQuIPP of products. **Job Qualifications** * BS, BA or Associate Degree in life sciences is preferred. * Minimum seven (7) years of related experience in QA or equivalent combination of education and experience. *… more
- Novo Nordisk (Durham, NC)
- …in Regulations & quality systems (eg, commercial product disposition, DV/ CAPA , Change Control, Audits, Supplier Management, Project Management, Validation, etc.) ... required + Experience with regulatory requirements computer system, such as 21 CFR Part 11, GAMP5, ISO, Data Integrity preferred + Experience with Risk Assessment & Vendor Assessments required + Minimum of four (4) years of experience in reviewing GMP… more
- Abbott (Alameda, CA)
- …which may include training, corrective action and preventive action ( CAPA ) activities, equipment maintenance, product and process planning, quality audits, ... validation, product development/clinical research, design control activities, complaints, and post market surveillance. + Work may require collaboration with other Division sites and/or other Abbott divisions. + Responsible for completing documentation in a… more
- Endo International (Rochester, MI)
- …live their best life. **Job Description Summary** The Senior Quality Specialist , Systems monitors, tracks, and trends Non-Conformances, CAPA , Complaints and ... of Time Continuous Improvement + Monitors, tracks, and trends CAPA and complaints, tracks due dates, analyzes data, prepares...+ Initiates communication due dates for Quality Systems (NCRs, CAPA , Complaints, etc.) to ensure they are completed on… more
