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 |
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| A. | 611Provides 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. Winston-Salem, NC30+ days ago The role requires shift work, full gowning, on-floor presence, and collaboration with Manufacturing, Quality Control, Facilities, and other stakeholders to ensure compliant and efficient manufacturing operations. The Specialist III applies solid cGMP expertise to perform documentation review, issue identification, escalation, and accurate records to ensure cGMP compliance. Morrisville, North Carolina13 days ago p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. Morrisville, North Carolina30+ days ago p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. Morrisville, North Carolina21 days ago p style="margin:0px">At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Job Summary: The Senior Quality Assurance Specialist is accountable for driving results in a fast-paced environment by effectively performing activities as directed to ensure quality and compliance with applicable regulatory requirements and internal procedures. Research Triangle Park, North Carolina21 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. li>Technical: Experience or familiarity with Quality Management Systems (e.g., Veeva, TrackWise) Demonstrated experience across key quality assurance functions in a GMP setting (e.g., batch record review, batch release functions, GxP document archival, as applicable). The QA Specialist, EMQO supports Quality Assurance activities at the Eisai Raleigh facility by assisting with routine operational quality tasks under direction and supervision. As a global leader in smallpox and mpox vaccines, our growing portfolio includes market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. The ideal candidate will have deep expertise in aseptic GMP manufacturing environments, strong knowledge of sterile operations, and hands-on experience managing quality oversight of external manufacturing partners. 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. 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. p>Vacancy Open to All Candidates Employment Type Permanent - Full-time If time-limited, note appointment end date Hours per week 40 Months per year 12 Position Number 009563 NC Salary Grade Equivalency NC09 Classification Title University Program Associate Working Title Lead Quality Assurance Specialist Salary Range $40,350 - $50,438 Anticipate Hiring Range $40,350 - $50,438 FLSA Status Non Exempt Division Business Affairs Department Facilities Management (Adm) Work Unit Facilities Management AVC Work Schedule. Monitor recurring facility and service-related issues to identify trends and support proactive efforts to improve conditions and reduce repeat deficiencies prior to formal inspections or audits. 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.
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. Research Triangle Park, NC19 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.
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. Greenville, NC30+ days ago You will partner cross functionally to drive quality excellence, ensure compliance with global regulatory requirements, and strengthen quality systems that support safe and effective products. Discover Impactful Work: As a Senior Quality Specialist, you will provide technical leadership and oversight within GMP manufacturing environments. Morrisville, NC26 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. 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. 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: 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, NC25 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. 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. Durham, North Carolina20 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: 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. 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 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. |