The Quality Management System (QMS) Specialist will play a key role in the oversight of the Quality Assurance (QA) program and quality systems at the site level to support on time closures and overall QMS health.
Maintain oversight of the QA program from a QMS perspective by driving on time closures and providing support for all records to ensure all systems remain compliantAssist with running weekly CAPA Review Board (CRB) to vet all CAPA proposals, communicate weekly and monthly forecasts and communicate any escalationsAssist with running weekly Quality Review Board (QRB) to cover all QMS records, holistically.
With emphasis on any Deviations or Complaints that are deemed to be CriticalDevelop and maintain high level dashboards for CAPAs, Deviations, Complaints and Change Controls based off of site KPIsPrepare periodic review of the quality system for quarterly Quality Management ReviewStrong collaboration, including problem solving and continuous improvement efforts, and communication with cross functional teamsWrite, review and approve Deviations, CAPAs, Complaints and Change Controls, as requiredLead and inspire cross-functional teams, driving a culture of compliance and continuous improvementDevelopment and execution of comprehensive remediation plans to address any gaps in the quality systemWork with cross-functional teams to implement compliance improvementsMaintain quality system KPIsOther responsibilities as required Who You Are : Minimim Qualifications : Associate's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 5+ years of experience in Quality Assurance and / or compliance roles within the pharmaceutical or biotechnology industryORBachelor's Degree in Microbiology, Biology, Medical Technology, Pharmacy, Biochemistry, Engineering, or other life science discipline with 3+ years of experience in Quality Assurance and / or compliance roles within the pharmaceutical or biotechnology industry Preferred Qualitfications : Strong focus on sterile manufacturing environmentsIn-depth understanding cGMP, Data Integrity and Quality SystemsProven track record of successfully leading and managing compliance remediation projects, ideally within sterile manufacturing facilitiesStrong project management skills, including the ability to prioritize tasks, manage timelines, and allocate resources effectivelyExcellent communication skills, both written and verbal, with the ability to convey complex compliance concepts to a range of audiencesExperience collaborating with regulatory agencies and conducting audits or inspections
Sr Principal Associate - QA, Quality Management Systems Deviation Lead - Parenteral Network
The Parenteral Network lead supports design and deployment of our core quality management system processes (with primary focus on Deviation Management), the related eQMS tool, and advanced technological capabilities (e. CAPA, changes, complaints, supplier quality management, auditing) across the Lil...
Quality Systems Specialist
Does Quality Systems Specialist sound like your next job title?. This exciting opportunity is offered by INCOG BioPharma Services, who is seeking a highly motivated Quality Systems Specialist to join at it's state-of-art CDMO during an exciting time of growth. Manager of QA, and will provide support...
Lead Specialist, Contract Lifecycle Management (CLM) Systems
Lead Specialist, Contract Lifecycle Management (CLM) Systems. The Lead Specialist, CLM Systems is an integral member of the US CLM team, who is instrumental in realizing CLM transformation vision and ongoing value delivery. The Lead Specialist, CLM Systems utilizes their experience and expertise to ...
Interim Director of Nursing - Weekly Pay: $2,000 - $2,400 *The above pay package is an estimate, please contact our team to put together your personalized pay package, as a variety of factors can influence your total pay.* Are you a passionate Director of Nursing looking to join a leadership team that operates with integrity? Would you like to join an organization that utilizes strengths and promotes from within? If you answered “yes” to these questions, please read on. We may have the perfect opportunity for you. The DON is responsible for oversight of the daily clinical and administrative operations of the nursing department to assure that each resident receives the highest quality of care so that they will achieve the maximum level of function in accordance with their comprehensive plan of care. When you join the LeaderStat team, you’ll be connected with a dedicated specialist before and during your assignment. They will work with you to coordinate onboarding, book and pay for travel arrangements, and assist with any questions along the way. Job Duties Plans, organizes, and directs overall clinical operations to provide comprehensive care for residents in accordance with current federal, state, and local guidelines Develops and implements nursing service objectives, policies, and procedures to maintain quality care and compliance Ensure adequate staffing levels across all shifts Oversee and evaluate nursing personnel Ensure compliance in all areas, including in documentation and resident care plans Qualifications At least two years of experience as a DON in a long-term care setting Active Registered Nurse (RN) license in Indiana or in an eligible Nurse Compact State Demonstrated competencies in health care management and operations, quality management, staff development, resident and family support systems, and community outreach Possess empathy and passion for serving others Serve as a leader and a trusted resource to other healthcare team members Strong computer literacy and competency skills Up-to-date clinical compliance Basic Life Support (BLS) or CPR via American Heart Association (AHA) Two-step TB test Physical exam within the last 12 months Benefits Weekly
Demonstrated competencies in health care management and operations, quality management, staff development, resident and family support systems, and community outreach. The DON is responsible for oversight of the daily clinical and administrative operations of the nursing department to assure that ea...
Quality Management Systems Specialist
The Quality Management System (QMS) Specialist will play a key role in the oversight of the Quality Assurance (QA) program and quality systems at the site level to support on time closures and overall QMS health. Maintain oversight of the QA program from a QMS perspective by driving on time closures...
Sr Principal Associate - QA, Quality Management Systems Deviation Lead - Parenteral Network
The Parenteral Network lead supports design and deployment of our core quality management system processes (with primary focus on Deviation Management), the related eQMS tool, and advanced technological capabilities (e. CAPA, changes, complaints, supplier quality management, auditing) across the Lil...
Lead Specialist, Contract Lifecycle Management (CLM) Systems
Lead Specialist, Contract Lifecycle Management (CLM) Systems. The Lead Specialist, CLM Systems is an integral member of the US CLM team, who is instrumental in realizing CLM transformation vision and ongoing value delivery. The Lead Specialist, CLM Systems utilizes their experience and expertise to ...
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