li>Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Akarsh Yathiraj| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611Research Triangle Park, North Carolina22 days ago Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical and preclinical studies, qualification and/or validation of methods, equipment/software validation, laboratory processes, etc. Must be able to effectively collaborate cross-functionally with peers, scientific and technical staff; and be comfortable working in a matrixed team. Durham, North Carolina30+ days ago Provides QA oversight of analytical and microbial laboratory activities including but not limited to method qualification, method transfers, method validations, creation and revision of test methods, specifications, stability studies, laboratory investigations and laboratory deviations. The Principal QA Specialist provides exemplary service to both internal and external customers by ensuring patient safety and regulatory compliance while supporting product lifecycle activities for timely delivery of products to clients for patients. As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. What You Will Do: - Perform day‑to‑day maintenance and administration of the QMS, including eQMS data entry, document updates, records management, monitoring system due dates, and responding to quality‑related requests from staff and project teams.
For additional information on Company employee benefits programs, visit https://careers.eisai.com/us/en/compensation-and-benefits. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Charlotte, NC30+ days ago Review and evaluate operational procedures, including Customer Service interactions from all communication channels, service requests, refund processing, Transponder fulfillment, outgoing correspondence, and future quality review implementations. Assists the Quality/Training Manager and Assistant Manager in auditing Key Performance Indicators (KPIs) for TTEC Operations, like outgoing correspondence and external survey results. Research Triangle Park, NC20 days ago Examples of activities within the scope of oversight and auditing include but are not limited to: preclinical animal studies, sample analysis from clinical (GCLP guidelines) and preclinical studies (GLP regulations), qualification and/or validation of methods, laboratory processes, etc. Education/ Qualifications:- Quality Assurance Specialist - Bachelor’s degree, in health care or relevant scientific field and 3+ years of relevant industry experience.
Charlotte, NC30+ days ago strong>What You Bring to the Role High school diploma or equivalent 6 months or more of customer service and call center experience Understanding, interpreting, and manipulating data for reporting What You Can Expect Supportive of your career and professional development An inclusive culture and community minded organization where giving back is encouraged A global team of curious lifelong learners guided by our company values Ask us about our paid time off (PTO) and wellness and healthcare benefits And yes. a great compensation package and performance bonus opportunities, benefits youd expect and maybe a few that would pleasantly surprise you (like tuition reimbursement) Use if US based role: Visit https://www.ttecjobs.com/en/us-employee-benefits for more information. Holly Springs, NC30+ days ago All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com). Holly Springs, NC26 days ago Provides QA oversight and supports DSM operations in accordance with governing processes and procedures• Provides QA support of DSM tasks such as o Batch Record and Solution Lot Record review, including exception-based oversight using Quality Review Management tool o Real time event triage and implementation of immediate response to identified deviations o Area changeover and return to service o Real time WO oversight per applicable procedures• Ensures department objectives are met within desired timelines and/or in accordance with identified KPIs• Contribute to the development of QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility• Participate in streamlining or efficiency improvement initiatives with other FUJIFILM Diosynth Biotechnologies sites. Minimum Requirements: BS/BA in Life Sciences or Engineering or equivalent with 2+ years of relevant experience OR• Masters in Life Sciences or Engineering or equivalent with 0 years' relevant experience• 1-3 years' experience in a GMP environment• Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. li>Leads, plans, organizes and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, approved suppliers and validation of methods, systems & instrumentation. Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients nationwide, offering laboratory solutions to life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints, and challenges. Morrisville, NC27 days ago Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives. In this role, the objectives would include improving clinical care as well as clinical documentation and reporting for treatment, prevention, and drug administration regimens, record keeping practices, workflow procedures, medical decision-making practices, and pay-for-performance programs. Chapel Hill, NC30+ days ago p>About the Role: - Lead trauma process improvement and patient safety initiatives for a Level I Adult & Pediatric Trauma Center, utilizing data-driven quality improvement strategies to enhance patient outcomes and reduce preventable trauma-related morbidity and mortality.
Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives.
li>Promotes the improvement of patient care and clinical excellence in clinical information systems via effective collaboration with healthcare providers, business and quality analysts, and leaders of clinical programs and quality initiatives. Assists OBGYN dept with meeting our Women's Health Improvement Collaborative goals for screening/treatment of depression, Social Drivers of Health, 5Ps, cervical cancer & breast cancer screenings. Are committed to creating work environments focused on mutual respect, teamwork, collaboration, and new ideas, through meaningful initiatives and training, partnerships with Veteran groups, to ensure we are building with top talent and harnessing our collective strengths within every aspect of our culture. Develops, evaluates, and maintains the quality assurance program processes including instructions, procedures, process documents, and requirement/guidance documents for implementation of the quality assurance program. p>The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Durham, North Carolina30+ days ago The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations. Monitor and analyze site quality metrics-including Deviations, CAPAs, Change Controls, Equipment Failures, EM data trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance. Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinsons disease, and Pompe disease. This key individual performs vendor assessments and occasional audits (virtual and on-site) alongside subject matter experts, ensuring vendor qualification activities support compliance with applicable GLCP, GLP, GCP, and GMP guidelines and relevant national/international/local regulations. This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: Durham, North Carolina21 days ago This includes performance of compliance review of records (master batch records, executed batch records, and internal support records such as logbooks), aid in deviation determination/generation, general Quality guidance. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities, including but not limited to: p>POSITION SUMMARY: The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing. Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules ? both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. p>Job Responsibilities: - Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
Minimum Requirements: - Minimum BS in scientific field with 14+ years' experience or MS and 11+ years' experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
Durham, North Carolina30+ days ago p/>Job Responsibilities: - Works directly with Manufacturing, QA and other departments responsible for GMP activities to resolve production related deviations and other compliance issues in a timely manner.
Minimum Requirements: - Minimum BS in scientific field with 14+ years’ experience or MS and 11+ years’ experience in a QA cGMP regulated environment within Biopharmaceuticals or equivalent.
li>Identifies non-conforming product and gathers pertinent information needed to help determine disposition. Perform physical and microbiological testing of finished products and other samples as required. p>The QA Specialist II, Quality Operations is responsible for quality operation activities related to clinical and commercial drug products in adherence with current Good Manufacturing Practices (cGMP) and corporate policies and procedures at the RTP campus. Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging activities. Research Triangle Park, NC4 days ago Escalate unresolved issues or concerns to Quality Management and affected area management + Participate in client meetings and projects as it relates to manufacturing, product scheduling, batch records, supply chain, etc. to support product pipelines + Support regulatory authority (FDA, MHRA, EMA, QP, etc.) inspections and internal audits, including documentation audit team, pre-audit facility inspections, etc Minimum Requirements + Bachelor’s Degree in a scientific or related technical discipline + 5+ years of relevant pharmaceutical industry experience in a cGMP regulated environment + Ability to work independently and part of a multi-functional team, being able to manage and prioritize workloads, stressful situations, and deadlines and work extended hours to support business needs + Able to work extended hours to support business needs, as applicable + Experience in review of batch records, production records, process control records + Ability to interpret data in relation to a vast number of company procedures as well as current GMP requirements + Ability to effectively communicate (written and oral) with internal and external customers at various levels in the organization + Ability to handle confidential company data, projects, information, etc. + Review GMP documentation, including logbooks, pest control, waterlogs, calibration and maintenance reports, temperature monitoring, batch records, protocols, etc., as it relates to Combination products for accuracy, completeness, and compliance with UT policies and procedures + Perform quality assurance functions, including inspection of production equipment for cleanliness, gowning, area line clearances, in-process packaging checks, AQL inspections and floor audits, in support of manufacturing and packaging operations + Review and disposition manufacturing, packaging and Combination Products batch records and raw materials and components for clinical and commercial processes + Review of quality control final product and stability data + Process rejected lots of raw materials, components and Combination products identified for destruction. p>Demonstrated solid Body of Knowledge of Quality systems and functions supporting drug or related FDA governed manufacturing obtained from professional Quality roles Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Ability to work effectively with others and communicate in customer-facing forums to progress issues and obtain positive results Able to navigate conflict to achieve deliverables and drive to targeted outcomes Ability to work professionally and facilitate positive interdepartmental interactions with a diverse group of people Voluntarily communicates needs and suggestions clearly and effectively Listens and is attentive to others' ideas and contributions. Durham, North Carolina30+ days ago If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.. Durham, North Carolina30+ days ago Includes a balance of, from such areas as Supplier Quality Assurance, Compliance, Audits/Inspections, Shop Floor Support, Batch / Material release, Quality document control, review and approval, Validation, QC, Deviations, Prior direct regulatory agency, and audit management /r support experience a plus. Minimum 5 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GMP Quality and Regulatory requirements. Greenville, NC30+ days ago We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Greenville, NC30+ days ago Our global organization of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. In this position, youll drive quality execution across the sterile operations including manufacturing, filling, packaging and inspection, and associated non batch specific activities in for both commercial and product development services products. Henderson, North Carolina30+ days ago div class="careers-description__container">Quality Assurance Specialist. • Address and discuss issues and proposed solutions with all department management teams and Regulatory/Compliance Manager. |