Collecting information
Organizing data
Ensuring that clinical trials and pharmacovigilance processes comply with applicable regulatory requirements, industry guidelines, and internal quality standards. Support the development, implementation, and maintenance of quality systems within clinical research programs and pharmacovigilance, working closely with cross-functional teams to promote a culture of compliance and continuous improvement. Collaborate with clinical, pharmacovigilance, regulatory, and operational teams to ensure quality standards are embedded throughout the clinical development lifecycle. Bachelor's Degree required (Masters preferred), ideally in biosciences or pharmacy; Minimum 5 years of experience in Clinical QA experience with relevant background in the pharmaceutical or biotechnology industry, including GCP/GVP regulatory inspections; Or a combination of education and experience. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs.
The Sr. Manager/ Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufacturing, packaging, testing, and supply of drug substance and drug products for use in clinical and commercial operations.. Manage batch record review, product investigations, deviations, complaints, change control, and other actions related to GMP activities, as required.. Work as part of cross-functional teams to advance a strong and mature data privacy and data protection program across the company, including key vendors and third-party providers. 10+ years of relevant experience in the area of GMP quality assurance in the pharmaceutical industry with at least 2 years in a managerial/leadership capacity. Significant hands-on experience with small molecule drug development in a biopharmaceutical company.
The Contact Center Quality RN is responsible for leading quality assurance and improvement initiatives to support departmental quality and education program. Pre-tax savings plans with healthcare and dependent care flexible spending accounts (FSA) and a health savings account (HSA).. Family-friendly support including adoption and fertility assistance, parental leave pay, military leave pay and a free Care.com membership with discounted backup care for your loved ones.. Employee Assistance Program (EAP): Referrals for childcare, eldercare, & pet care. Access free legal guidance, mental health visits, work-life support, digital self-help tools and more.
Accura HealthCare of Cresco has the opportunity to welcome a Quality Assurance and Infection Preventionist Nurse (RN) to join our team!. If you desire an organization that creates an environment that allows both our residents and team members to thrive, consider Accura HealthCare and join us in being partners in care, family for life. Our employees play a key role in supporting our purpose, "to care for others," while advancing our mission "to be partners in care, family for life. OUR BRANDS: Accura HealthCare | Stonebridge Suites | Traditions Memory Care. The Quality Assurance and Infection Preventionist Nurse applies knowledge and experience by offering guidance pertaining to infection control, skin assessments, safety and resident rights, training, education, etc.
Lead and manage the deviation, investigations, CAPA, and Change Control program across Manufacturing, QC, and other GxP functions.. Own and/or continuously improve SOPs, workflows, and tools related to investigations, CAPA, Change Control and deviation management.. Minimum of 7 years of experience in quality and/or in a pharmaceutical, biotech, or biologics cGMP regulated manufacturing environment preferred.. Deep knowledge of cGMPS, ICH Q9 (Quality Risk Management), FDA regulatory expectations.. Proficient in electronic QMS tools (e.g., Veeva, MasterControl, TrackWise, etc
Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. As the Director, IT Computer System Validation & Quality Assurance, you will play a pivotal role in ensuring the compliance, reliability, and quality of our computer systems within the biotechnology domain. Own and evolve the organization's CSV framework across GxP and non-GxP systems. Ensure that validation activities meet regulatory and business requirements for systems like Veeva Vaults, QMS, Safety systems and custom applications.. Experience working with Veeva Development Cloud Vaults and Commercial solutions
Job Title: Quality Assurance Manager-Good Clinical Practice (GCP). Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance.. Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations.. Experience working in Quality Assurance GCP internal and client audits (minimum 5 years).. Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred.
The position manages the Food Safety Quality Assurance (FSQA) program for the Eastern Region.. Collaborate with the regulatory compliance team and act as a liaison between federal and state agencies to ensure compliance with regulatory requirements.. Technical knowledge of regulatory requirements, including FSMA, microbial hazards, third-party audit bodies, sanitation procedures, and field and plant operations.. A bachelor's degree in microbiology, Food Sciences, Agriculture, Regulatory Compliance, or a related field is required.. PCQI certification preferred
Individuals in Quality Assurance, Monitoring & Testing are responsible for the assessment of outcomes from activities and processes against conformance with applicable requirements to strengthen risk management quality such as quality testing performed for business function quality control and transformation lead quality control post completion of an activity/process.. Have a good understanding of the Citi Risk & control framework and the underlying fundamentals on Risk. + Support to ensure that risk and control responsibilities and accountabilities are embedded within Central Testing Utility. Minimum of 6-10 years of experience in operational risk management, compliance, audit, or other control-related functions in the financial services industry.. Analytical Thinking, Assurance Strategy, Communication, Constructive Debate, Controls Assessment, Controls Lifecycle, Policy and Procedure, Risk Remediation, Stakeholder Management.
Our new Lilly Kenosha County facility will be one of Lilly’s most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction. Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement/enhancement initiatives are described. Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems).. Participate in the Site Lead Team and lead the Quality Lead Team. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).
Conducts audits to assure compliance with METRO standards, contract requirements, and applicable codes, specifications, and drawings, including but not limited to: Planning, Design, Engineering, Estimating, Procurement, Project Controls, Document Control, Vendor/Subcontractor Management, Receiving, Handling & Storage, Construction, etc.. Works with EVP-PEC in resourcing Quality Staff to grow the Quality Organization within PE&C and make recommendations on the development of an Agency level Quality Program.. Performs or directs independent audits of external project design and construction by consultants and contractors, including audits of quality records and practices; coordinates the implementation of corrective actions regarding QA/QC deficiencies.. Maintains best practices and lessons learned documentation and issues bulletins to PEC and METRO staff to increase efficiency of workflows.. The Metropolitan Transit Authority of Harris County, Texas has a zero tolerance drug and alcohol policy for all employees.
Director of Quality Assurance and Compliance - Recovery | Fair Oaks Recovery Center | Sacramento, California.. Coordinates regulatory activities including licensure, certification and accreditation (OHFLAC, BHHF, CMS, Joint Commission, CARF, ASAM, Office of Civil Rights, etc.. Why Fair Oaks Recovery Center?. Fair Oaks Recovery Center offers a comprehensive benefit plan and a competitive salary commensurate with experience and qualifications. Fair Oaks Recovery Center is an EOE.
Our new Lilly Kenosha County facility will be one of Lilly's most technically advanced manufacturing sites and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will result in safety and quality improvements, increased productivity, and variability reduction.. Ensure the site has a CAPA program and a quality plan where corrections and corrective actions and significant quality improvement/enhancement initiatives are described.. Ensure that a process of governance and control is in place (Quality Lead Team, established Deviation Review Board, Change Control Board, CAPA board) to ensure monitoring of quality indicators applied to each element of the quality system, discuss the results and actions to improve Quality Management systems and execution (Management Review of Quality Systems). Participate in the Site Lead Team and lead the Quality Lead Team. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).
Proven track record of building effective relationships with Stakeholder Agency UAT Test Leads, DAS leadership, and vendor partners. Experience in planning UAT resource capacity and schedules in coordination with leadership and other UAT Test Leads. Ability to collaborate with the DAS UAT Automation Test Lead to determine which test scripts should be automated. Experience in coordinating and executing testing across systems including Eligibility & Enrollment, Call Center, Document Management, and Automated Functions (BOTS). Experience in a leadership role within a UAT or Quality Assurance setting.
First and foremost, an intimate knowledge of U.S. Regulations governing deposit operations is a MUST. This knowledge should include payment processing, card operations, wires, fraud, business and consumer banking, fair banking laws, AML and BSA.. Minimum 2 years of branch or deposit operations experience required.. Operating within the first line of defense (1LoD), this role will support the Chief Operating Office (COO) through the monitoring, testing, enhancing, and sustaining an effective Risk and Control environment through performing quality assurance related routines in accordance with RBC Bank's Risk Management and Compliance Frameworks/Policies/Standards and US Regulatory requirements.. Provides compliance support for all U.S. Deposit Operations, including but not limited to Reg CC, Reg DD, Reg E. Critical Thinking, Decision Making, Detail-Oriented, DevOps, IT Quality Assurance, Long Term Planning, Planning Ability, Process Management, Project Development, QA Project Management, Quality Assurance (QA), Risk Management, Software Product Testing, Test Automation
The Quality Assurance Supervisor is responsible for the supervision of employees in the Quality Assurance and Food Safety Department on their respective shift and work with Quality Assurance Manager in motivating and developing employees.. Work with QA Manager in implementing programs and on assigned projects.. Participate in training employees in accordance with our training program on GMPs, HACCP and SQF.. Bachelors of Science Degree in Food Science, Biology, Chemistry or related field, or at least 3-5 years' experience in the quality assurance field required.. Elevate Your Workplace Experience with Community Impact Opportunities.
Goodwill of Southwestern Pennsylvania and North Central West Virginia is a nonprofit organization that funds job training, education, and other community programs by selling donated clothing and household items in Goodwill stores and online.. Data Systems Proficiency: Advanced experience with database platforms (e.g., CaseWorthy, HMIS, and CWDS), and strong skills in data tools such as Power BI, Tableau,. Performance Measurement: Expertise in designing KPIs, benchmarks, and outcome metrics relevant to diverse program models (e.g., workforce development, housing, disability).. CQI Methodologies: Strong knowledge and effective application of quality frameworks such as Total Quality Management (TQM), PDSA, and Lean Six Sigma to drive. Candidates are expected to provide current, valid clearances (Child Abuse Clearance, FBI Fingerprints Clearance, and PATCH) prior to first day of employment.
The Quality Assurance Program Manager (QAM) is primarily responsible for leading the development and implementation of data center construction project-specific quality programs in alignment with the QTS Quality Assurance Program.. The QAM will interact with data center construction project teams, including trade partners and vendors, to ensure adequate control measures are performed and produce the expected outcomes, and lead the corrective action when found otherwise.. Experience with Procore and PowerBI. Experience with delivery of mission critical data center facilities.. This role is also eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401(k) retirement plan; flexible spending and HSA accounts; paid holidays; paid time off; paid volunteer days; employee assistance program; tuition assistance; parental leave; military leave assistance; QTS scholarship for dependents; wellness program, and other company benefits.
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology.. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs.. Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures. In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices
The position is responsible for serving as a lead QA representative for Raw Materials and Batch Records to ensure timely, compliant, and efficient release in support of manufacturing operations.. Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records.. Perform Qrelated entries and reviews in inventory management systems (e.g., SAP or LIMS) related to raw material status changes (quarantine/release/reject).. Support periodic audit readiness activities and participate in internal walkthroughs to ensure data integrity and documentation alignment across QA processes.. Collaborate with QA Systems to support trending and KPI reporting related to raw material and batch record review cycle times.