Referral Coordinator ClareMedica Health Partners LLCReferral CoordinatorPalm Beach Gardens, FLWhile performing the duties of this job, the employee will be required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; climb stairs, balance; stoop, kneel, crouch or crawl; talk or hear. Proficient skills in Microsoft Office Suite products including Word, PowerPoint, Outlook and Excel plus a variety of other word-processing, spreadsheet, database, e-mail and presentation software.
NewQuality Assurance Officer Hyatt Vacations OwnershipQuality Assurance OfficerBonita Springs, FLMeet and actively engage with customers to present the contract and related documents to ensure they have a firm and accurate understanding of the product purchased and its terms and conditions, that the product purchased fulfills the customer’s needs, and that the purchase process has adhered to all Company policies and business guidelines. Collaborate with Sales, Contracts, Underwriting, and other departments to ensure uniform messaging to customers and deliver a smooth and efficient closing experience, including collaboration with different levels of employees within other departments where necessary.
NewQuality Assurance Officer- Key West Sales Hyatt Vacations OwnershipQuality Assurance Officer- Key West SalesKey West, FLMeet and actively engage with customers to present the contract and related documents to ensure they have a firm and accurate understanding of the product purchased and its terms and conditions, that the product purchased fulfills the customer’s needs, and that the purchase process has adhered to all Company policies and business guidelines. Collaborate with Sales, Contracts, Underwriting, and other departments to ensure uniform messaging to customers and deliver a smooth and efficient closing experience, including collaboration with different levels of employees within other departments where necessary.
Supervisor, Quality Assurance Swisher International, Inc.Supervisor, Quality AssuranceJacksonville, FLWith a rich history, Swisher serves adult consumers through a diverse range of businesses, including Swisher Sweets Cigar Company, Helme Tobacco Co., Hempire, Rogue Holdings, and Drew Estate: The Rebirth of Cigars. This role requires strong leadership skills, technical expertise, and the ability to drive continuous improvement initiatives.
NewOrder Management Coordinator Vaco LLCOrder Management CoordinatorJacksonville, FL$45,000–$50,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
QA/QC Field Coordinator - Miami, FL Ceco Concrete Construction, LLCQA/QC Field Coordinator - Miami, FLMiami, FLAssociate’s Degree in Architecture, Construction Management or related field plus 1 year of work experience supporting key position responsibilities or equivalent combination of education and/or construction quality-related work experience. Supports proficient use of internal quality assurance systems and tools to assist with preparing reports for field superintendents, project managers and subcontractors detailing compliant and non-compliant conditions.
RN Coordinator | Freestanding Emergency Department | Full Time | Nights UF HealthRN Coordinator | Freestanding Emergency Department | Full Time | NightsGainesville, FL$78,811.20–$135,512Assists with clinical coverage schedules, and serves as a clinical expert for patient care and services in the unit by providing clinical leadership support and direct patient care if staffing requires. Motor Vehicle Operator Designation: Will not operate vehicles for an assigned business purpose Licensure/Certification/Registration: Current RN license in state of Florida.
Lead QA/Testing Coordinator Kforce Inc.Lead QA/Testing CoordinatorMiami, FL$65–$75Experience with payment source types, cancellations, returns, late payments handling processes, reactivation of product subscriptions scenarios, promo pricing, taxation elements, global retail sales (transactions and ship-to global delivery models). Salesforce Cloud: Strong background in Sales Cloud, Service Cloud, and Commerce Cloud workflows, including lead generation > opportunity > account > purchasing with subscriptions model with various recurring payment types.
NewQuality Manager JobotQuality ManagerSanford, FL$110,000–$120,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. We are seeking a detail-oriented and proactive Quality Manager to lead and oversee all quality assurance and food safety programs within our manufacturing operations.
NewPreschool Quality Assurance Specialist (3253) Lutheran Services FloridaPreschool Quality Assurance Specialist (3253)West Palm Beach, FLMeet monthly with site managers/liaisons to keep them abreast of new developments in the Head Start Program on state regional and national levels or program changes concerning Head Start/Early Head Start. Requires a bachelor’s degree in Social Work, Social Services, Early Childhood Education OR Early Childhood Development; OR Business Administration with relevant experience related to Head Start Operations.
NewCase Management Coordinator IconmaCase Management CoordinatorNorth Miami, Aventura, Hialeah or Miramar Counties, FLOur client, a Retail Pharmacy company, is looking for a Case Management Coordinator for their North Miami, Aventura, Hialeah or Miramar Counties, FL location. Educate/empower colleagues at all levels to enable decision making at most appropriate level.
Quality Assurance Executive- Orlando Sales Office Marriott Vacations WorldwideQuality Assurance Executive- Orlando Sales OfficeOrlando, FLReach overhead and below the knees, perform bending, twisting, pulling, and stooping, and be able to stand, sit, or walk for an extended period of time. Fulfill requests from Owners regarding pricing, property maps, property descriptions, room locations, and portfolio/network information. .
NewInternet Sales Coordinator Lennar CorporationInternet Sales CoordinatorMiami, FLLennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional customer service, giving back to the communities in which we work and live in, and fostering a culture of opportunity and growth for our Associates throughout their career. May require the ability to work more than eight hours per day in the confined quarters of a construction trailer, the ability to operate a motor vehicle, read plans, climb stairs and ladders, bend, stoop, reach, lift, move and/or carry equipment which may be in excess of 50 pounds.
NewEngineering Data Coordinator Keller North America, Inc.Engineering Data CoordinatorTampa, FLThe successful candidate will receive information from Project Managers, Project Assistants, Field Engineers, Superintendents, and other project stakeholders and enter that information into company databases and internal systems. This individual will play a critical role in ensuring project data is accurately captured, organized, and available for use by engineering, project management, and field teams.
Quality Assurance Director - Nuclear Engineering - Florida Michael Page USAQuality Assurance Director - Nuclear Engineering - FloridaPalm Springs, FL$150,000–$185,000 / yearFull timeThe Director of Quality Assurance leads the development and execution of a nuclear-grade quality program, guiding the organization from early-stage engineering into regulated manufacturing and fuel production operations. Building the quality framework for future manufacturing operations, including inspection, testing, traceability, non-conformance, and corrective action processes.
HSEQ Coordinator Keller North America, Inc.HSEQ CoordinatorMiami, FL$76,000–$95,000 / yearActual salary will be based on a variety of factors including relevant internal and external experience, knowledge, skills, scope of job, geographical location or other factors permitted by law . By connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges.
Quality Control Inspector II Medline IndustriesQuality Control Inspector IIAuburndale, FL$19–$27.50 / hourFull timeResponsibilities include investigating and documenting held finished goods, managing holds and releases, completing rework assignments, inspecting raw materials and finished goods using various methods, recording inspection results, providing product disposition, ensuring inventory control, performing final inspections, and ensuring compliance with quality procedures and company policies. Strong attention to detail, including the ability to read and understand labeling information, discern differences in similar products or packaging, and identify differences in character sequences (e.g., Lot, Expiration, Date of Manufacture).
NewPathology Lab Manager PRECISION HEALTHCARE SPECIALISTS LLCPathology Lab ManagerFort Myers, FLThe ideal candidate has strong leadership skills, a background in pathology or clinical laboratory science, and experience managing a high-volume lab environment. Description: Precision Healthcare Specialists is seeking an experienced Pathology Lab Manager to oversee the operations of our pathology laboratory.
NewARNP Community Resource Coordinator, DJJ Eckerd ConnectsARNP Community Resource Coordinator, DJJFort Myers, FLThe purpose of the After Care Resource Navigator Program is to increase positive outcomes for youth who are reentering the community from a residential commitment facility by identifying and establishing relationships with resources that address the service needs of youth and families, connecting youth served by the Program and their families with the appropriate resources to address their specific service needs. These include but are not limited to resources for: Mental health services, substance abuse services, sex offender services, educational services, vocational service es, mentoring services, temporary housing services, family support services, family support services, employment services, and community service assistance.
NewSAP Fieldglass System Coordinator Kforce Inc.SAP Fieldglass System CoordinatorDoral, FLRemote$22–$28Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. Primary Purpose: The candidate provides hands-on operational support for SAP Fieldglass (VMS) to maintain system stability and support an ongoing system expansion initiative.
HSEQ Coordinator Moretrench IndustrialHSEQ CoordinatorRiverview, FLBy connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges. In this hands-on position, you will work directly with the Business Unit Safety Manager with the following: Assisting with directing safety and environmental hazard activities for the region.
HSEQ Coordinator Moretrench IndustrialHSEQ CoordinatorRiverview, FLBy connecting global resources and local experience, Keller develops innovative, practical, and cost-effective solutions to geotechnical challenges. In this hands-on position, you will work directly with the Business Unit Safety Manager with the following: Assisting with directing safety and environmental hazard activities for the region.
NewRental Coordinator Lead - Jaguar Land Rover North Dade Warren Henry Automotive GroupRental Coordinator Lead - Jaguar Land Rover North DadeNorth Miami, FLHigh school diploma or general education degree (GED), or minimum one year of related experience and/or training, or equivalent combination of education and experience. The role also includes training new hires, ensuring compliance with company policies, and providing support during staffing shortages to maintain smooth daily operations.
Rental Coordinator - Lincoln North Miami Warren Henry Automotive GroupRental Coordinator - Lincoln North MiamiNorth Miami, FLHigh school diploma or general education degree (GED), or minimum one year of related experience and/or training, or equivalent combination of education and experience. The Rental Coordinator will be responsible for receiving orders, generally in person, for rentals or loaner vehicles.
NewBusiness Support Coordinator System OneBusiness Support CoordinatorPine Hills, FLManage inventory levels and master sheets for CORE cases, ancillary items, MiFis, Starlinks, tech boxes, clothing, hard hats, and general office supplies in the Field Service building. Manage audits to ensure technology received from outages, including MiFi, iPad, and cases, are in working order and up to date with the latest iOS before outage season.
Advanced Energy - Director of Quality - Palm Beach, FL Michael Page USAAdvanced Energy - Director of Quality - Palm Beach, FLPalm Beach Gardens, FL$150,000–$190,000 / yearFull timep class="PDq2pG_selectionAnchorContainer">Our client is seeking a Director of Quality Assurance to establish and lead a comprehensive nuclear quality assurance program supporting engineering, procurement, supplier oversight, manufacturing readiness, and future fuel production activities. The company is currently transitioning from research and engineering development into commercialization and is seeking experienced leaders to help build the systems, processes, and organizational capabilities necessary for long-term growth.
NewCustomer Service Coordinator Penske Truck RentalCustomer Service CoordinatorFT. PIERCE, FLDevelop daily and weekly workforce plans by factoring customer needs, estimated unscheduled repairs, available parts, technician skill sets and work hours to maximize customer service and productivity. • Willingness to travel as necessary, work the required schedule, work at the specific location required, complete Penske employment application, submit to a background investigation (to include past employment, education, and criminal history) and drug screening are required.
NewQuality Control Specialist System OneQuality Control SpecialistMiami, FL$48,006.40 / yearWe are seeking a detail-oriented Quality Control Specialist to support program compliance, quality assurance, and performance monitoring within a Housing Choice Voucher (HCV) environment. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Customer Service Coordinator PenskeCustomer Service CoordinatorFort Pierce, FLFull timeDevelop daily and weekly workforce plans by factoring customer needs, estimated unscheduled repairs, available parts, technician skill sets and work hours to maximize customer service and productivity. • Willingness to travel as necessary, work the required schedule, work at the specific location required, complete Penske employment application, submit to a background investigation (to include past employment, education, and criminal history) and drug screening are required.
NewCommunity Outreach Coordinator Lifespace CommunitiesCommunity Outreach CoordinatorLongwood, FL$41,700–$57,300 / yearSee Lifespace Communities Terms & Conditions at https://www.appcast.io/legal/#job-seeker-terms-of-use and Privacy Policy at https://www.appcast.io/privacy-policy and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions. Lifespace Communities headquartered in West Des Moines, Iowa and Dallas, Texas, is one of the nation's largest Senior Living providers of non-profit retirement communities.
Lost & Found Coordinator Marriott Vacations WorldwideLost & Found CoordinatorOrlando, FLManages all resort lost & found processes including logging, tracking, coordinating, shipping, & returning items, managing inventory, purging/ donating unclaimed items and generating necessary reports. Develop and maintain positive working relationships with others, support team to reach common goals, and listen and respond appropriately to the concerns of other employees.
ECMO Specialist | Full TIme | 3/12s | ECMO | Gainesville UF HealthECMO Specialist | Full TIme | 3/12s | ECMO | GainesvilleGainesville, FL$70,158.40–$121,492.80Motor Vehicle Operator Designation: Employees in this position: Will not operate vehicles for an assigned business purpose NOTE: A frequent driver is defined as one who uses his/her personal or Shands automobile a) at least once daily, b) at least five individual trips per week or c) drives, on average, over 150 miles per week in the performance of his/her job. Qualifications: Minimum Education and Experience Requirements: Either a graduate of an accredited Respiratory Therapy program, with current State of Florida licensure as a Registered Respiratory Therapist, or a graduate of an accredited Registered Nurse program, with a current State of Florida licensure.
ECMO Specialist 3-12 UF HealthECMO Specialist 3-12Gainesville, FL$70,158.40–$121,492.80Motor Vehicle Operator Designation: Employees in this position: Will not operate vehicles for an assigned business purpose NOTE: A frequent driver is defined as one who uses his/her personal or Shands automobile a) at least once daily, b) at least five individual trips per week or c) drives, on average, over 150 miles per week in the performance of his/her job. Qualifications: Minimum Education and Experience Requirements: Either a graduate of an accredited Respiratory Therapy program, with current State of Florida licensure as a Registered Respiratory Therapist, or a graduate of an accredited Registered Nurse program, with a current State of Florida licensure.
NewEstimating Manager JobotEstimating ManagerPort Canaveral, FL$130,000–$150,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. With a strong presence in the Mid-Atlantic region, they specialize in structural steel design, engineering, detailing, fabrication, erection, and retrofitting of existing structural members.
NewNephrology Nurse RN Educator-Coordinator kidney care preferred ChenMedNephrology Nurse RN Educator-Coordinator kidney care preferredNorth Miami, FL$76,732–$109,617The Patient Educator, Specialty (RN), is also accountable for the development and delivery of clinical education to patients that increases their knowledge of disease processes, improves patient engagement in care, and reduces hospital and ER admissions. The incumbent in this role is responsible for helping to improve patient health outcomes by promoting and facilitating disease education with the patient and/or family member(s) thereby ensuring their active involvement in care and care decisions.
Manager of Design Engineering Brains Workgroup, Inc.Manager of Design EngineeringHialeah, FLFull timeDirect and manage the performance of the group’s circuit, components and sub-assemblies’ analysis and simulation efforts employing commercially available EDA Software including PSpice, Method of Moments (MoM), Finite Element Method (FEM) engines (i.e. Genesys, ADS, HFSS, CST), and other CAD tools. Lead team to create and implement an optimum design flow and strategy geared to lower turnaround times, increase component’s performance and rate of 1st spin success while ensuring manufacturability, improving yields, and lowering costs.
NewProgram Manager CAIProgram ManagerMiramar, FL$60–$70This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment. If you have strong experience leading cross-functional engineering programs, managing dependencies, and driving risk mitigation and progress tracking, and are looking for your next career move, apply now.
Periop Service Line Coord -CVT | FT days UF HealthPeriop Service Line Coord -CVT | FT daysJacksonville, FLSpecific course work: Graduate of an accredited school of nursing Preferred Education: MSN Required Licensure/Certifications: -Licensed to practice nursing in the state of Florida -BLS from the American Heart Association or American Red Cross -Effective July 1, 2018 all new hires or transfers must obtain/maintain Certified Nurse Operating Room (CNOR) certification within three years (3) years of hire or transfer. Overview: The Perioperative Cardiothoracic-Vascular procedures Service Line Coordinator is responsible for overseeing the coordination of care for patients undergoing cardiothoracic-vascular procedures.
NewIT Business Analyst, Digital Platforms Herc Rentals IncIT Business Analyst, Digital PlatformsBonita Springs, FLCollaborate Effectively: Work closely with cross-functional teams, including IT, product owners, and business stakeholders to gather and document business requirements for digital platform initiatives. Please be advised that the actual salary offered for any position is subject to the company's sole discretion and may be influenced by various factors, including but not limited to the candidate's qualifications, experience, location, and overall fit for the role.
MIA Training Coordinator CovenantMIA Training CoordinatorMiami, FLThis role is responsible for developing and maintaining training materials, facilitating instructor-led training, overseeing on-the-job training activities, tracking employee training records, and ensuring all required certifications remain current. Ability to stand, walk, sit, reach, bend, stoop, and climb stairs for extended periods while conducting training sessions, classroom instruction, operational observations, and quality assurance activities.
Internet Sales Coordinator Lennar HomesInternet Sales CoordinatorMiami, FLFull timeLennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional customer service, giving back to the communities in which we work and live in, and fostering a culture of opportunity and growth for our Associates throughout their career. May require the ability to work more than eight hours per day in the confined quarters of a construction trailer, the ability to operate a motor vehicle, read plans, climb stairs and ladders, bend, stoop, reach, lift, move and/or carry equipment which may be in excess of 50 pounds.
Regional Marketing Field Coordinator Lennar HomesRegional Marketing Field CoordinatorMelbourne, FLFull timeLennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional customer service, giving back to the communities in which we work and live in, and fostering a culture of opportunity and growth for our Associates throughout their career. The Regional Marketing Field Coordinator serves as the on-the-ground marketing partner at the divisional level, supporting local community execution, New Home Consultants (NHC), and division/regional marketing initiatives.
NewPurchasing Coordinator Lennar HomesPurchasing CoordinatorPensacola, FLFull timeLennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional customer service, giving back to the communities in which we work and live in, and fostering a culture of opportunity and growth for our Associates throughout their career. Requires the ability to work more than eight hours per day in the confined quarters of a construction trailer, the ability to operate a motor vehicle, read plans, climb stairs and ladders, bend, stoop, reach, lift, move and/or carry equipment which may be in excess of 50 pounds.
Point of Care Quality Coordinator HCA Healthcare IncPoint of Care Quality CoordinatorJacksonville, FLYou Will: · Analyze proficiency testing samples · Review proficiency testing and/or quality assurance results and work with departments to develop corrective action plans, where indicated · Complete all required records/documentation pertaining to quality assurance and/or point-of-care testing records · Monitor accreditation agency licensing status and assist department director in preparing licensing and renewal paperwork (CAP, CLIA, AHCA, business license, etc.) · Prepare annual assessment of Quality Control, Quality Assurance and Regulatory compliance under the guidance of the Department director · Participate in the evaluation, selection, and implementation of point-of-care testing equipment in support of facility service needs You Should Have: · A 2 Year/Associate Degree required · 4 Year/Bachelor's Degree in Medical Technology preferred · A State of Florida Technologist License OR the ability to obtain during the interview process · A State of Florida Supervisor's License is preferred · 3-5 Years of Experience in a clinical laboratory setting with quality assurance and/or point-of-care testing Benefits HCA Florida Memorial Hospital, offers a total rewards package that supports the health, life, career and retirement of our colleagues. Our infrastructure includes a fully automated esoteric core laboratory in Fort Lauderdale, a histology and microbiology operation in Largo, Florida, and a network of hospital based rapid-response laboratories present in four HCA Healthcare divisions within the state of Florida.
Associate Quality Assurance Coordinator Assurant IncAssociate Quality Assurance CoordinatorMiami, FL$19.08–$30.53 / hourA Fortune 500 company with a presence in 21 countries, Assurant supports the advancement of the connected world by partnering with the world's leading brands to develop innovative solutions and deliver an enhanced customer experience through mobile device solutions, extended service contracts, vehicle protection services, renters insurance, lender-placed insurance products, and other specialty products. Named a Best/Great Place to Work in 14 countries and awarded the Fortune America's Most Innovative Companies recognition, we bring together top talent around the world.
Pharmacy Quality Coordinator Curant HealthPharmacy Quality CoordinatorSt Petersburg, FloridaOur culture of caring is evident by being recognized as one of Inc.’s fastest growing healthcare companies, receiving the Georgia Fast 40 and Atlanta Business Chronicle Trendsetters awards every year since 2013. Utilize ObserveAI as a training and performance improvement resource to enhance the quality of phone calls and patient interactions.
RN Quality Coordinator HCA Healthcare IncRN Quality CoordinatorJacksonville, FLWhat qualifications you will need: (RN) Registered Nurse Associate Degree Hospital patient safety / risk management experience 2 years experience Required Years of Experience Benefits HCA Florida Memorial Hospital, offers a total rewards package that supports the health, life, career and retirement of our colleagues. Apply share Share Email X Facebook LinkedIn bookmark_border Save Job bookmark Unsave Job // Save Jobs functionality detectsavedjob('1-INFOR-4667482','save-job','unsave-job');
DC Quality Assurance Coordinator W.W. Grainger IncDC Quality Assurance CoordinatorJACKSONVILLE, FL$19.23–$24.04 / hourRewards and Benefits: With benefits starting on day one, our programs provide choice and flexibility to meet team members individual needs, including: Medical, dental, vision, and life insurance plans with coverage starting on day one of employment and 6 free sessions each year with a licensed therapist to support your emotional wellbeing. At Grainger, We Keep the World Working by serving more than 4.6 million customers worldwide with maintenance, repair and operating (MRO) products and value-added solutions delivered through innovative technology and deep customer expertise.
Regulatory Quality Improvement Coordinator RN Hospice AdventHealthRegulatory Quality Improvement Coordinator RN HospiceAltamonte Springs, FL$60,748.67–$97,197.90 / yearKnowledge, Skills, and Abilities: Knowledge of nursing skills in the performance of duties in compliance with the legal and ethical parameters established and based on the level of education and certification attained by the employee. Coordinates with the Quality Service and Risk Coordinator to maintain tracking database integrity and provide reports to other departments.
Quality Assurance Coordinator (Clinical Research) Research Centers of AmericaQuality Assurance Coordinator (Clinical Research)Hollywood, FLPart timeGCP, and ICH guidelines; Able to take a flexible approach to shifting priorities; Able to manage multiple projects and responsibilities; Motivated to work consistently in a fast paced and rapidly changing environment; Must be detail oriented and have exceptional computer, organizational, and communication skills – both written and oral. Performs ongoing review of a percentage sampling of study inclusion/exclusion, study procedure records, and laboratory reports to ensure that they are conducted according to the protocol, applicable SOPs, ICH/GCP guidelines and federal regulations.