Quality Assurance Specialist jobs at QTC Management - 1427 jobs

A leading biopharmaceutical company in California is looking for a seasoned Quality Lead to define and execute the quality strategy for Development Electronic Systems, focusing on the integration of emerging technologies like AI. The ideal candidate should possess over 13 years in the pharmaceutical industry, demonstrating exceptional leadership and problem-solving capabilities. This role emphasizes cross-functional collaboration, risk management, and fostering a culture of continuous improvement while ensuring compliance with regulatory standards. #J-18808-Ljbffr

Responsible for maintaining compliance with all State, Federal regulatory guidelines and third party payers; Accreditation standards and quality activities of the organization. Provides leadership and expertise to facilitate and support staff competency through best practice teaching, consultation, collaboration and the use of current knowledge, research and technology. Essential Functions: Ensures that there are processes in place to monitor and measure all activities related to quality assessment and performance improvement (QAPI). Provides direction and coordination of quality improvement activities utilizing continuous quality improvement principles and methodologies. Provides education and training to organization personnel on the QAPI plan, and team development. Performs clinical record review activities for data collection. Compiles, analyzes, trends and reports quality data in the following areas: hospice & palliative care quality reporting, patient care, safety, risk management, infection control, outcomes and customer satisfaction. Works collaboratively with nursing supervisors/managers/directors to assure documentation is complete and consistent with care and reflects legal requirements. Promotes professional standards of care, compliance with regulatory requirements, third-party payor reimbursement models, and organization policies and procedures through use of performance improvement methodology. Ensures complete responses to Additional Development Requests (ADRs), Comprehensive Error Rate Testing (CERT), Recovery Audit Contractor (RAC) etc., requests and participates in appeal processes. Participates in the development and annual revision of Quality Assessment and Improvement Plans and Program Evaluation. Participates in analyzing, developing, coordinating and implementing plans of correction for noted deficiencies. Makes recommendations to the education committee for mandatory education related to accreditations and compliance topics. Acts as a mentor and resource for staff with regard to performance improvement methodology, regulatory, educational and patient care issues. Participates in the evaluation, development and revision of policies and procedures for hospice. Participates on various committees related to Organizational Quality and Education. Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal and professional networks. Adheres to organizational Code of Conduct, policies, procedures, protocols and processes and all regulatory and legal requirements Adheres to the C.A.R.E. Model of Service: courtesy, acknowledgement, response and empathy. Qualifications: Registered Nurse with a baccalaureate degree in nursing, preferably a Master's Degree in a health-related discipline. Minimum three (3) years' direct hospice experience may be considered in lieu of BSN degree. Requires two to three years related quality and accreditation experience. Current RN licensure in State of Michigan and maintain such licensure in accordance with applicable laws and regulations and perform within the scope specified. Extensive knowledge of Hospice regulations and standards preferred. Excellent written, verbal and interpersonal skills necessary to interact with a wide variety of staff. Is self-directed and able to work with minimal supervision. Requires knowledge of quality assessment and utilization review functions, principles and practices. Theoretical and practical knowledge of principles of adult learning and ability to develop and present educational programs. Quantitative, analytical and computer skills to collect, analyze, display and present data. The physical and sensory demands of the position include: vision, effective speech and hearing for extensive telephone contact; repetitive motion; traveling; driving or riding in motor vehicle; standing, sitting, walking, bending, reaching, and stretching; lifting up to forty five (45) pounds unassisted and the ability to assist in lifting patients using appropriate lifting techniques and/or devices. Must be able to work variable hours/shifts and/or days, including weekends. Must have ability to occasionally work extended days. Must be eligible to work in the United States.

The primary responsibility for this position is to establish phase appropriate product specifications for Gilead's clinical and commercial products. In addition, this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s). The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team, Manufacturing, and Analytical functions, Supply Chain, RA CMC, and the wider PDM Quality organization. Job Functions Expert in analytical control systems, assuring network-wide harmonization of control systems by proactive lifecycle management, technical leadership and ownership. Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development, validation, transfer, and monitoring) and product (process development, CQA analysis, stability, comparability, etc). Ability to evaluate Global product filing strategies with core PDM Team for implementation. Provide timely support for health authority interactions on the product, authorship/review (as needed) relevant health authority information requests for in-process controls, process development (comparability), method validation, specifications, reference standard, and stability sections of regulatory submissions. Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities. Accountable for end-to-end quality compliance of the assigned product/program, which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log. Serve as the primary Quality representative in the PDM meeting. Lead Product Quality Teams (PQT) supporting the product/program, and ensure visibility and communication of strategy, key project timelines and CMC milestones. Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified, mitigated and, if necessary, escalated in a timely manner. Review and approve the strategy for change control(s) impacting the product/program lifecycle. Provide technical oversight of Major and/or Critical Deviations, CAPAs, Biological Product Deviation and Complaints. Contribute to Review Regulatory Submissions (IND, IMPD, BLA, NDA, MAA), and assist with regulatory communications as needed (e.g. responses to agency information requests, the Notified Body Option). Provide oversight for changes to drug substance and drug product CMC details. Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites. Support drug substance and drug product technology transfer, and new product launches. Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products. Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering, development, and quality teams. Facilitate Analytical Strategy (stability strategy, specifications, Critical Quality Attributes). Perform work that requires independent decision making and the exercise of independent judgment. Serve as the delegate for direct manager, as needed, for meeting and decision making. Knowledge, Experience and Skills Well verse in technical requirements for product control systems. Strong knowledge and practical experience in analytical chemistry, including separation science, wet chemistry, physicochemical characterization or related areas. Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions. In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally. Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles. In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Skilled at managing multiple projects and timelines and to facilitate meetings. In-depth understanding and execution of Quality Risk Management. Ability to track and follow up on actions. Excellent in verbal, written and interpersonal communication skills. Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way. Ability to lead and influence a matrix-based cross-functional team. Critical and strategic thinking skills and ability to provide pragmatic, risk-based, and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined. Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product. Basic Qualifications 12+ years of relevant experience and a Bachelor's degree in science or related fields. OR 10+ years of relevant experience and a science degree MS OR 8+ years PhD Preferred Qualifications Prior Quality leadership and technical management experience in development and/or commercial programs. 15+ years of relevant experience and a Bachelor's degree in science or related fields; or 10+ years of relevant experience and an advanced science degree such as MS, PharmD, PhD or an advanced business degree such as an MBA. Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment. Direct experience with regulatory health authority submissions (e.g. IND, NDA, BLA, MAA) and/or inspections. Broad experience across several including process validation, drug development experience, packaging/labeling and understanding of Parenteral, Oral Solid Dosage, and Biologics. Job Requisition ID R0047720 Full Time/Part Time Full-Time Job Level Director Remote Type Onsite Required #J-18808-Ljbffr

A leading biopharmaceutical company in California is seeking a Senior Director for Global Supplier Quality. The successful candidate will lead a team of Quality Professionals, ensuring compliance with GMP standards while managing supplier quality initiatives. This role requires extensive experience in biopharmaceutical management, exceptional leadership skills, and a strong understanding of regulatory requirements. Candidates should have a solid educational background in science and proven leadership experience in complex organizations. Competitive salary & benefits are offered. #J-18808-Ljbffr

A leading biotechnology firm located in California is seeking a Director of Quality Assurance to oversee product quality and establish specifications for clinical and commercial products. The role requires extensive experience in analytical chemistry and regulatory compliance, along with strong leadership skills in a complex matrix environment. This is a full-time on-site position offering the opportunity to lead strategic quality initiatives. #J-18808-Ljbffr

The CQM Supervisor oversees non-clinical auditors in the Clinical Quality Management (CQM) department, ensuring regulatory compliance and the quality of processes in daily Non-Clinical Utilization Management (UM) activities, under the direction of a manager. This Supervisor is responsible for conducting live audits of UM case files, assigning drivers and presenters, and ensuring their performance is appropriate. The role also involves monitoring UM system controls and processes, specifically those that do not require clinical decisions. A solid understanding of comprehensive regulations, UM policies and procedures, the UM system, UM auditing, and quality improvement is essential for this position. Essential Duties and Responsibilities: - Familiarity with Non-Clinical UM regulations, processes, and systems. - Ability to assign workloads effectively while managing staff. - Proficient in presenting case files and conducting interviews regarding non-clinical questions. - Skilled in designing audit tools to monitor Non-Clinical UM processes completed by non-clinical staff. - Strong communication skills for effective interaction with internal clients and external customers. - Capable of training employees using Policies & Procedures (P&Ps) and audit tools. - Provide constructive feedback and exhibit strong active communication skills. - Summarize quality monitoring findings, analyze root causes, and propose quality improvement plans. - Suggest and design focused audits that help improve compliance in Non-Clinical UM processes. - Request decision support for creating and enhancing Non-Clinical UM monitoring reports based on changes to UM P&Ps. - Ensure auditors complete audits and necessary remediation within specified timeframes. - Collaborate with the Non-Clinical UM team to ensure monitored focus areas are addressed and that process quality is tracked. - Work with operational teams to evaluate the effectiveness and efficiency of process changes made for quality improvement. - Ensure that new processes are accurately implemented through reports and case file reviews. - Report issues identified to the Prior Authorization Compliance Director based on findings. - Review updated policies and procedures, and be able to update the quality monitoring tool accordingly. - Maintain all evidence related to quality monitoring projects. - Track and manage daily reports received from the decision support team. - Report any issues related to internal processes (e.g., timeliness) to the CQM manager. - Attend department meetings, in-house services, and trainings, completing acknowledgments within the required timeframe. - Perform all other duties as directed by management. Education and Experience: - Three to five (3-5) years of experience in non-clinical utilization management. - Preferred: at least two (2) years of experience in non-clinical UM supervision or auditing. - Proficiency in MS Office programs (Word, Excel, Outlook, Access, PowerPoint). - Typing speed of 60 words per minute with accuracy. - Ability to handle confidential matters responsibly. - Strong analytical, creative problem-solving, and organizational skills. - Capacity to work in a multi-tasking, high-stress environment. - Effective strategy execution within timelines, delivering quality results. - Ability to adapt and thrive in a fast-paced environment, demonstrating proactivity. - Capable of managing multiple projects simultaneously, adjusting priorities daily, and knowing when to seek assistance with conflicting priorities. - Self-motivated, assertive, ambitious, and possessing high personal ethics. - Ability to collaborate with all levels of management and establish positive working relationships across various divisions in the company. Compensation: The pay range for this position at the start of employment is expected to be between $70,304 and $72,000 annually, depending on experience. However, the base pay offered may vary based on multiple individual factors, including market location, job-related knowledge, licensure, skills, and overall experience. The total compensation package for this position may also include other elements, such as a sign-on bonus and discretionary awards, along with a full range of medical, financial, and other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), depending on the position offered. Details regarding participation in these benefit plans will be provided to employees who receive an employment offer. If hired, the employee will be in an “at-will position,” and the company reserves the right to modify base salary (along with any other discretionary payments or compensation programs) at any time, including for reasons related to individual performance, overall company performance, or market factors. As one of the fastest-growing Independent Physician Associations in Southern California, Regal Medical Group, Lakeside Community Healthcare, and Affiliated Doctors of Orange County offer a dynamic and fast-paced work environment. Employer will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the LA City Fair Chance Initiative for Hiring Ordinance.

$24K SIGN ON BONUS FULL TIME NIGHTS, WEEKENDS ONLY BETHESDA NORTH RESPIRATORY SERVICE Provides respiratory care in all patient care settings, also includes duties of those of an RRT, with specialized knowledge and skills in the areas of Critical Care, Airway management, Advanced Life Support and Mechanical Ventilation of all ages. Responsibilities include first-line adult or neonatal intubation, transport of newborns, and acts as a preceptor in the clinical training of residents, nurses, and students in the advanced practice of pulmonary medicine and therapeutic procedures. Job Requirements: Graduate of an approved technical, professional, or vocational program Basic Life Support for Healthcare Providers (BLS) and ACLS if providing adult intubations NRP if providing neonatal intubations NBRC registry RCP licensure in Ohio 3-4 years experience in a related field Job Responsibilities: Performs all necessary documentation, updates work lists, and submits all charges by the end of the shift. Demonstrates skill and proficiency in the management of the Respiratory Evaluation Protocol Program Demonstrates proficiency as specialist in ventilator management and critical care for adults and neonates Demonstrates proficiency and competency in the management of adult and neonatal airways. Demonstrates proficiencies as specialist in recommending, initiating and performing specialized clinical procedures to help diagnose, treat and/or improve patient situations Other Job-Related Information: In order to remain in this position, this individual must do at least one intubation per quarter and a total of six per year. This individual must also maintain a 90% success rate over a year period or repeat an OR Working Conditions: Climbing - Rarely Hearing: Conversation - Frequently Hearing: Other Sounds - Frequently Kneeling - Rarely Lifting 50+ Lbs. - Rarely Lifting Pulling - Occasionally Pushing - Occasionally Reaching - Occasionally Sitting - Occasionally Standing - Frequently Stooping - Occasionally Talking - Frequently Use of Hands - Frequently Color Vision - Frequently Visual Acuity: Far - Frequently Visual Acuity: Near - Consistently Walking - Frequently TriHealth SERVE Standards and ALWAYS Behaviors At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, ALL TriHealth team members are expected to demonstrate and live the following: Serve: ALWAYS Welcome everyone by making eye contact, greeting with a smile, and saying hello Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist Refrain from using cell phones for personal reasons in public spaces or patient care areas Excel: ALWAYS Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met Offer patients and guests priority when waiting (lines, elevators) Work on improving quality, safety, and service Respect: ALWAYS Respect cultural and spiritual differences and honor individual preferences. Respect everyones opinion and contribution, regardless of title/role. Speak positively about my team members and other departments in front of patients and guests. Value: ALWAYS Value the time of others by striving to be on time, prepared and actively participating. Pick up trash, ensuring the physical environment is clean and safe. Be a good steward of our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste. Engage: ALWAYS Acknowledge wins and frequently thank team members and others for contributions. Show courtesy and compassion with customers, team members and the community

$19K Sign On Bonus Full Time Day GOOD SAM HOSPITAL RESPIRATORY - Adult and Neonatal ICU requirements Provides respiratory care in all patient care settings, also includes duties of those of an RRT, with specialized knowledge and skills in the areas of Critical Care, Airway management, Advanced Life Support and Mechanical Ventilation of all ages. Responsibilities include first-line adult or neonatal intubation, transport of newborns, and acts as a preceptor in the clinical training of residents, nurses, and students in the advanced practice of pulmonary medicine and therapeutic procedures. Job Requirements: Graduate of an approved technical, professional, or vocational program Basic Life Support for Healthcare Providers (BLS), and ACLS if performing intubations NBRC registry or RRT RCP licensure in Ohio 3-4 years experience in a related field Job Responsibilities: Performs all necessary documentation, updates work lists, and submits all charges by the end of the shift. Demonstrates skill and proficiency in the management of the Respiratory Evaluation Protocol Program Demonstrates proficiency as specialist in ventilator management and critical care for adults and neonates Demonstrates proficiency and competency in the management of adult and neonatal airways. Demonstrates proficiencies as specialist in recommending, initiating and performing specialized clinical procedures to help diagnose, treat and/or improve patient situations Other Job-Related Information: In order to remain in this position, this individual must do at least one intubation per quarter and a total of six per year. This individual must also maintain a 90% success rate over a year period or repeat an OR Working Conditions: Climbing - Rarely Hearing: Conversation - Frequently Hearing: Other Sounds - Frequently Kneeling - Rarely Lifting 50+ Lbs. - Rarely Lifting Pulling - Occasionally Pushing - Occasionally Reaching - Occasionally Sitting - Occasionally Standing - Frequently Stooping - Occasionally Talking - Frequently Use of Hands - Frequently Color Vision - Frequently Visual Acuity: Far - Frequently Visual Acuity: Near - Consistently Walking - Frequently TriHealth SERVE Standards and ALWAYS Behaviors At TriHealth, we believe there is no responsibility more important than to SERVE our patients, our communities, and our fellow team members. To achieve our vision and mission, ALL TriHealth team members are expected to demonstrate and live the following: Serve: ALWAYS Welcome everyone by making eye contact, greeting with a smile, and saying hello Acknowledge when patients/guests are lost and escort them to their destination or find someone who can assist Refrain from using cell phones for personal reasons in public spaces or patient care areas Excel: ALWAYS Recognize and take personal responsibility to address and recover from service breakdowns when a customer's expectations have not been met Offer patients and guests priority when waiting (lines, elevators) Work on improving quality, safety, and service Respect: ALWAYS Respect cultural and spiritual differences and honor individual preferences. Respect everyones opinion and contribution, regardless of title/role. Speak positively about my team members and other departments in front of patients and guests. Value: ALWAYS Value the time of others by striving to be on time, prepared and actively participating. Pick up trash, ensuring the physical environment is clean and safe. Be a good steward of our resources, using supplies and equipment efficiently and effectively, and will look for ways to avoid waste. Engage: ALWAYS Acknowledge wins and frequently thank team members and others for contributions. Show courtesy and compassion with customers, team members and the community

The position description is a guide to the critical duties and essential functions of the job, not an all-inclusive list of responsibilities, qualifications, physical demands, and work environment conditions. Position descriptions are reviewed and revised to meet the changing needs of the organization. TITLE: Clinical Documentation Specialist RN JOB OVERVIEW: The Clinical Documentation Specialist position facilitates accurate documentation for severity of illness and quality in the medical record. This involves extensive record review, interaction with physicians, health information management professionals, and nursing staff. Active participation in team meetings and education of staff in the documentation improvement process is a key role. DEPARTMENT: Health Information Management HOURS OF WORK: Days Monday - Friday. RESPONSIBLE TO: Manager, Clinical Documentation Improvement PREREQUISITES: * Current unrestricted WA State Registered Nurse license, required. * Bachelor's degree in Nursing, preferred. * Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review * Pass a pre-hire Clinical Exam with a minimum score of 70% * Effective communication with Providers QUALIFICATIONS: * Knowledge of hospital clinical practice standards for physicians and other health care providers. * Knowledge of ancillary service departments, quality control and safety standards. * Critical thinking, problem solving and deductive reasoning skills. * Familiarity with health care audit and research design. * Knowledge of Pathophysiology and Disease process. * Functional knowledge of DRG coding systems. * Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies. * Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities. * Meet productivity guidelines. * Ability to learn/develop the skills necessary to perform and meet goal standards * Organizational, analytical, writing, and interpersonal skills * Dependable, self-directed, and pleasant * Critical thinking, problem solving and deductive reasoning skills * Knowledge of Pathophysiology and Disease Process * Basic Computer skills - familiarity with Windows based software programs * Knowledge of regulatory environment * Understand and support documentation strategies (upon completion of training) * Knowledge of Core Measure and Patient Safety Indicators (upon completion of training) UNIQUE PHYSICAL/MENTAL DEMANDS, ENVIRONMENT AND WORKING CONDITIONS: See Generic for Administrative Partner. PERFORMANCE RESPONSIBILITIES: A. Generic Job Functions: See Generic Job Description for Administrative Partner. B. Essential Responsibilities and Competencies * Reviews EMR for completeness and accuracy for severity of illness and quality using the documentation strategies. * Accurate and timely record review. * Recognize opportunities for documentation improvement. * Initiates severity worksheet for inpatients. * Formulate clinically credible documentation clarifications. * Request documentation clarifications as appropriate for SOI, Core Measures, and Patient Safety. * Effective and appropriate communication with physicians. * Timely follow up on all cases and resolution of those with clinical documentation clarifications. * Communicates with HIM staff and resolves discrepancies. * Accurate input of data for reconciliation of case. * Provide necessary information and education to physicians and staff to facilitate the appropriate documentation goals. * Identify any barriers to completion of documentation goals with appropriate interventions. * Review of regulations and coding guidelines through seminars, meetings, and materials. * In cooperation with the director of PFS/HIM, present education sessions to physicians and other VMC providers regarding documentation regulations and chart audit findings. * Maintains confidentiality of all accessible patient financial or medical records information. * Demonstrates the awareness of the importance of cost containment for the department. Provide suggestions regarding process or quality improvement opportunities to department manager. * Other duties as assigned to facilitate accurate, timely patient account management. Date Created: 5/18, updated 7/22 Grade: NC11 FLSA: E Cost Center: 8490 Job Qualifications: PREREQUISITES: * Current unrestricted WA State Registered Nurse license, required. * Bachelor's degree in Nursing, preferred. * Minimum five years recent clinical experience as an RN working in an acute care setting or with experience in Utilization Review * Pass a pre-hire Clinical Exam with a minimum score of 70% * Effective communication with Providers QUALIFICATIONS: * Knowledge of hospital clinical practice standards for physicians and other health care providers. * Knowledge of ancillary service departments, quality control and safety standards. * Critical thinking, problem solving and deductive reasoning skills. * Familiarity with health care audit and research design. * Knowledge of Pathophysiology and Disease process. * Functional knowledge of DRG coding systems. * Working experience with Utilization Review activities and general knowledge of JCAHO, PRO, HCFA, and other regulatory bodies. * Knowledge of third-party payer review, reimbursement systems and utilization monitoring requirements for acute care facilities. * Meet productivity guidelines. * Ability to learn/develop the skills necessary to perform and meet goal standards * Organizational, analytical, writing, and interpersonal skills * Dependable, self-directed, and pleasant * Critical thinking, problem solving and deductive reasoning skills * Knowledge of Pathophysiology and Disease Process * Basic Computer skills - familiarity with Windows based software programs * Knowledge of regulatory environment * Understand and support documentation strategies (upon completion of training) * Knowledge of Core Measure and Patient Safety Indicators (upon completion of training)

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). Collect site metrics for selection of investigator site audits while analyzing and reporting trends. Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. Provide QA support for clinical study programs with GCP compliance, as needed. Assist during health authority inspections, including document management and logistical coordination. Support and contribute to risk management analysis efforts associated with GCP functions. Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Facilitate ongoing quality improvement through communication of audit results and CAPAs Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). Keep up to date with all related quality legislation and compliance issues. Requirements: Bachelor's degree in a science discipline is required. 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. 2 years of relevant experience in GxP function providing Quality and Compliance oversight. Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. California pay range $80,000-$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities * Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). * Collect site metrics for selection of investigator site audits while analyzing and reporting trends. * Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. * Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. * Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. * Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. * Provide QA support for clinical study programs with GCP compliance, as needed. * Assist during health authority inspections, including document management and logistical coordination. * Support and contribute to risk management analysis efforts associated with GCP functions. * Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. * Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. * Facilitate ongoing quality improvement through communication of audit results and CAPAs * Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). * Keep up to date with all related quality legislation and compliance issues. Requirements: * Bachelor's degree in a science discipline is required. * 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. * 2 years of relevant experience in GxP function providing Quality and Compliance oversight. * Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: * Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. * Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). * Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial.

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Quality Assurance Specialist will participate in the activities in support of the GCP and the Quality Assurance departments at Arrowhead to ensure compliance with GCP standards. This includes support in investigator audit programs, risk management plans, regulatory inspections, generating metrics for continuous improvement, and quality events while collaborating cross-functionally to uphold clinical trial quality and regulatory compliance. Key responsibilities include assisting in GCP Quality Event management (non-conformances, deviations, CAPAs, SCARs), contributing to risk-based audit planning, support in audits and inspections, procedural reviews and collaborating closely with the Clinical Operations team to ensure GCP compliance and data integrity. Responsibilities Develop and maintain clinical quality study risk plans and maintain updates in the Quality Management System (QMS). Collect site metrics for selection of investigator site audits while analyzing and reporting trends. Lead and participate in internal audits to identify gaps, ensure adherence to policies, and drive corrective actions. Assist with audit-related data entry in the QMS and documentation to maintain accurate and organized records and do develop dashboards for internal sharing. Conduct periodic reviews of SOPs to verify compliance with regulatory requirements and organizational standards. Support in the issuance, tracking and completion of deviations, SCARs (supplier corrective action requests) and CAPAs. Provide QA support for clinical study programs with GCP compliance, as needed. Assist during health authority inspections, including document management and logistical coordination. Support and contribute to risk management analysis efforts associated with GCP functions. Assist and/or support risk identification efforts at the asset / IP, therapeutic area, clinical study, clinical site, and vendor level. Communicate risk management mitigations and activities to the Manager Clinical Quality Assurance, Quality Assurance, and Clinical Operations and Development Teams. Facilitate ongoing quality improvement through communication of audit results and CAPAs Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches). Keep up to date with all related quality legislation and compliance issues. Requirements: Bachelor's degree in a science discipline is required. 3 years of relevant experience in a regulated environment with preference to quality assurance, auditing and/or GCP experience. 2 years of relevant experience in GxP function providing Quality and Compliance oversight. Requires occasional travel to other Arrowhead locations (San Diego, CA; Verona, WI; San Diego, CA) Preferred: Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations and ICH guidelines. Prior experience with use of an electronic document management system in a regulated environment is preferred (Veeva). Knowledge of using Artificial Intelligence (AI) and/or building AI models (i.e., training dataset creation, validation, and reassessment) is beneficial. California pay range $80,000-$95,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

We are seeking a Quality Assurance Specialist to ensure our products and operations comply with all applicable U.S. federal, state, and local regulations. This role will play a critical part in bridging communication with our Korea HQ, overseeing product compliance, import documentation, product quality-related customer claims (VOC), and regulatory audits. You will be a key contributor in maintaining operational excellence in a fast-growing beauty retail environment. What Youll Do Review and approve product documentation for store onboarding, including ingredient lists and label compliance in accordance with U.S. regulations. Evaluate claims, marketing materials, and packaging to ensure regulatory accuracy. Manage and investigate product quality-related customer claims (VOC), and lead response efforts for product recalls or regulatory inquiries (e.g., FDA, state agencies). Ensure compliance of physical retail operations with local legal and regulatory standards. Provide training and guidance to store staff on compliance-related matters. Manage import documentation and respond to customs-related issues to ensure smooth clearance and delivery. Maintain regular communication with our Korea HQ regarding product specifications, documentation, and compliance updates. Establish, maintain, and enhance compliance policies in accordance with U.S. federal and state regulatory requirements. Monitor changes in product regulations (e.g., MoCRA, FD&C Act) and proactively recommend necessary updates. Review supplier audit documentation and conduct on-site inspections when necessary to ensure manufacturing practices meet quality and regulatory standards. Qualifications 5-10 years of experience in quality assurance, preferably in a U.S.-based beauty or personal care platform Bachelors degree or higher in a relevant field (e.g., Chemistry, Biotechnology, Life Sciences) In-depth understanding of U.S. and international regulatory frameworks (FDA, ISO standards, etc.) Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements Preferred Qualifications Experience working in quality assurance roles at major U.S. beauty retailers or platforms Bilingual in English and Korean Experience with ISO 22716 certification or compliance (GMP for cosmetics) Familiarity with cross-border operations and global supply chain regulatory challenges

is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. JOB RESPONSIBILITIES: Performs compliance review on the following records: release, in-process, and stability data. Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations. MINIMUM REQUIREMENTS: BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Be able to sit for long periods of time. Ability to lift 20 pounds. Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. 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. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. 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.

Peregrine Team is hiring for a Quality Assurance Specialist in Charlotte, NC. This position is a full-time, contract to hire role with full benefits and competitive pay. Charlotte, NC, United States (Remote) Remote | Must reside local to Charlotte, NC Contracted About the Role We are seeking a temporary, highly detail-oriented Quality Assurance Specialist to support our team with data cleansing, auditing, and consistency checks across our systems. This temporary position plays a critical role in ensuring the accuracy, completeness, and reliability of information used throughout the organization. The ideal candidate will be meticulous, process-driven, and comfortable working with large datasets and various software systems. This role may also provide technical support to team members as needed. Key Responsibilities Perform data entry, updates, and verification in multiple systems. Conduct data cleansing to ensure accuracy, consistency, and completeness of information. Identify and correct data anomalies, duplicates, and formatting issues. Execute data audits and quality checks to maintain system integrity. Assist with documentation of data management processes and findings. Collaborate with team members to identify data quality improvement opportunities. Provide basic technical support related to system access, data uploads, and error troubleshooting. Maintain confidentiality and handle sensitive information securely. Qualifications Proven experience in data entry, data management, or data quality assurance. Strong attention to detail and commitment to accuracy. Proficient in Microsoft Excel or Google Sheets; familiarity with databases or CRM systems a plus. Strong organizational and time-management skills. Excellent communication and problem-solving abilities. Ability to work independently and meet deadlines in a fast-paced environment. Prior experience providing basic tech support or troubleshooting data-related issues preferred. Email your resume to [email protected] ASAP or apply here for consideration.

We're searching for a Coding Quality Assurance Specialist II - someone who works well in a fast-paced setting. In this position, you will assign and audit the accuracy of the ICD-10-CM and CPT codes to ambulatory, emergency center, observation, and day surgery records for purposes of billing, research, and providing information to government and regulatory agencies. Ascertains the accuracy of the physicians' E/M and procedure coding to their documentation, completes the auditing reporting tool, and provides feedback to the education team and/or provider. Think you've got what it takes? Job Duties & Responsibilities • Assigns ICD-10-CM, ICD-10-PCS, and CPT codes. • Reviews and interprets documentation for appropriate diagnosis and procedures. • Communicates with and provides feedback to the education team and/or provider. • Identifies principle and secondary diagnoses and procedure codes from the electronic medical and/or paper record. • Utilizes the encoder or coding books to correctly assign all ICD-10-CM, ICD-10-PCS, and CPT codes for diagnosis and procedures. • Sequences diagnosis and procedures to generate appropriate ICD-10-CM, CPT, PCS, and DRG codes for billing. • Queries physicians to obtain clarification or missing elements in the record preventing correct coding. • Utilizes other available resources for assignment of codes as necessary (e.g., Epic, MIQS, Cardio IMS, Logician, and coding reference materials). • Assists other coders in resolving coding problems/questions. • Provides ICD-10 and CPT, for physician research projects, and reporting purposes. • Completes abstracts for records when appropriate. • Identifies problem accounts. • Corrects problem accounts. • Participates in education and maintains certification. • Assists in auditing records. • Maintains concurrent coding for inpatient records. Skills & Requirements • Required High School Diploma or GED • Required Licenses/Certifications o CCA - Certified Coding Associate by the American Health Information Management Association (AHIMA) o CCS - Cert-Cert Coding Specialist by the American Health Information Management Association (AHIMA) o CCS-P - Cert-CCS-P Physician Based by the American Health Information Management Association (AHIMA) o CIPC - Certified Inpatient Coder by the American Academy of Professional Coders (AAPC) o COC - Certified Outpatient Coder by the American Academy of Professional Coders (AAPC) o CPC - Cert-Cert Professional Coder by the American Academy of Professional Coders (AAPC) o CRC - Cert Risk Adjustment Coder by the American Academy of Professional Coders (AAPC) o RHIA - Cert-Reg Health Inform. Admins by the American Health Information Management Association (AHIMA) o RHIT - Cert-Reg Health Inform. TECH by the American Health Information Management Association (AHIMA) • Required 2 years' experience in coding **Outpatient, Professional coding experience in the following specialties HIGHLY DESIRED: General Surgery, Plastics, Oto and Ortho

We are seeking a highly motivated QA Manufacturing Specialist I/II at our state-of-the-art commercial manufacturing facility in Patriot Park, Durham, NC. You will have the unique opportunity to help build our site processes and culture as we ramp up to full manufacturing capacity. We embrace KBI's values of learning and growth, high standards, collaboration, and trust and respect to solve problems and continuously improve. As a center of excellence, our site enables real-time quality and process monitoring through paperless records with integrated automation. We are looking for a critical thinker who is comfortable tackling new challenges / unknowns and utilizing a risk-based approach. We hope you join us! Position Responsibilities: Be an on-the-floor quality partner working with the manufacturing team during operations Work with manufacturing and other groups to escalate and resolve deviations and other compliance issues Conduct QA walkthroughs Participate in safety walkthroughs Participate in process improvements Attend relevant meetings in support of manufacturing operations Review electronic batch records and logbooks Provide feedback on facility response for unplanned events Other tasks and projects as assigned Work 12-hour shifts (2-2-3 schedule, day shift) Position Qualifications: MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. MQA Specialist II Associate degree / bachelor's degree strongly preferred or appropriate years of experience (approximate 3-5 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Ability to support internal and external audits. Demonstrated ability to train employees on Quality subjects. Ability to track and trend department metrics Salary Ranges: MQA Specialist I: $54,000 - $74,300 MQA Specialist II: 66,966 - 92,077 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. 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. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. 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.

We're hunting for a Professional Ambulatory Clinical Documentation Specialist, someone who's ready to be part of the best ranked children's hospital in Texas, and among the best in the nation. In this position, you will be responsible for the reviewing, education, development, and training of our Physicians and staff as it relates to reimbursement and CPT and ICD coding compliance. Think you've got what it takes? Job Duties & Responsibilities • Develops and implements a method by which each TCPA & TCPSO physician has a representative sample of his/her medical records reviewed on a routine and frequent basis. • Provides feedback to physician and Director on the educational opportunities found from the reviews. Recommends improvement opportunities to documentation practices and coding changes to physician based on information. • Provides feedback to the Director on any Medicaid compliance issue found from the reviews. • Develops and implements training programs for Physicians, Front Office, and CBO staff to reinforce and/or change the documentation and coding behaviors found from the review. • Educates and reinforces the most appropriate documentation used to optimize quality and reimbursement that TCPA & TCPSO physicians utilize. Where appropriate, this should include education on coding guidelines were quality documentation is already present but not coded to the appropriate level • Focused on root cause identification and process improvement specific to documentation accuracy and completeness. • Engages in process and quality improvement initiatives. • Reviews and interprets the Federal Registry and other relevant publications on a current and regular basis to be aware of coding changes that may affect TCPA & TCPSO as well as the industry. • Responds directly to all telephone and written requests for documentation and coding information accurately and timely. • Acts as a risk adjustment documentation and coding resource, including education and physician engagement. Skills & Requirements • Required associate degree with a preferred bachelor's degree • Four years of healthcare experience will substitute for the required associate degree • Required Licenses and Certifications o CPC - Cert-Cert Professional Coder American Academy of Professional Coders (AAPC) o CCDS DOC - Cert-Cert Clinical Doc. SPCLST Association of Clinical Documentation Improvement Specialist (ACDIS) o CDIP - Cert-Clinical Doc. Impr. PROF American Health Information Management Association (AHIMA) o CCS-P - Cert-CCS-P Physician Based American Health Information Management Association (AHIMA) o CIPC - Certified Inpatient Coder American Academy of Professional Coders (AAPC) o COC - Certified Outpatient Coder American Academy of Professional Coders (AAPC) o CDEO Certified Documentation Expert Outpatient American Academy of Professional Coders (AAPC) o CCDS-O Certified Clinical Documentation Specialist Outpatient Association of Clinical Documentation Improvement Specialist (ACDIS) • Preferred Pediatric Experience

The Clinical Documentation Specialist (CDS) improves the accuracy and completeness of clinical documentation in medical records by performing thorough reviews and requesting clarifications from clinicians. They facilitate modifications that accurately reflect patient severity, risk, and resource use, collaborating with clinicians and coders. The CDS ensures compliance with regulatory guidelines and supports accurate reporting of provider and hospital outcomes. They actively contribute to operational improvements and participate in education and program-related activities, aligning with FMOLHS Mission values. Job Responsibilities: 1. Documentation Review a. Performs assigned CDI reviews of inpatient medical records with concentration on review priority as designated (such as those payors with prospective payment methodology). b. Performs accurate and thorough initial and follow up CDI medical record reviews as assigned, within productivity standards. c. Documents CDI review findings, following processes and guidelines. d. Submits queries to physicians, seeking clarity on significant diagnoses, procedures, complications and/or co-morbidities, as indicated, in order to facilitate a comprehensive, clear and complete medical record. e. Consistently demonstrates accurate data entry regarding CDI activity, contributing to efficiency and accuracy of CDI metrics and initiatives. 2. Quality a. Operates within the compliance guidelines of Medicare and Medicaid Services. b. Considers compliance and displays ethical decision-making skills. c. Understands and complies with policies and procedures related to confidentiality of medical records. d. Demonstrates actions consistent with FMOLHS Mission, core values and service standards as daily duties are performed. e. Demonstrates standards of performance that support patient satisfaction, principles of service excellence, all applicable laws, regulatory agencies and accrediting bodies. f. Facilitates accuracy and completeness of documentation used for measuring and reporting provider and hospital outcomes. g. Maintains accurate and complete record review and query outcome to comply with departmental and regulatory guidelines. 3. Collaboration/Partnership a. Collaborates with physicians and other clinical disciplines to clarify clinician documentation, which is incomplete, conflicting, or non-specific. b. Educates physicians and other clinical disciplines on best documentation practices, in conjunction with CDI and Coding leadership, as well as physician advisors. c. Serves as a resource to clinicians for linking medical terminology and coding guidelines for improved accuracy in code assignment. d. Assists with communication between coders and physicians for retrospective querying. e. Collaborates with Health Information Management regarding coding analysis and education initiatives for physicians and other clinical disciplines. f. Consults with leadership and/or other clinical disciplines in matters of uncertainty. g. Demonstrates standards of performance that support patient satisfaction and principles of service excellence. h. Communicates effectively with other team members, physicians and customers while always remaining tactful and friendly. i. Participates in CDI program related meetings, clinician education, staff development, departmental activities, and opportunities. 4. Research/Knowledge a. Demonstrates knowledge of ICD-10 Official Coding Guidelines, and ability to interpret documentation for appropriate working codes, resulting in the correct working DRG assignment. b. Demonstrates ability to interpret medical record documentation to determine the appropriate principal diagnosis and procedure, resulting in the appropriate DRG. c. Demonstrates ability to correlate clinical information/ detail and medical record documentation terminology for appropriate documentation clarification opportunities. d. Demonstrates knowledge of diagnosis specificity clarification opportunities, which could result in greater specificity and accuracy in code assignment. e. Initiates appropriate and accurate documentation clarification requests (queries), facilitating modifications to the medical record documentation for accurate reflection of the patient' s severity of illness, risk of mortality and resource utilization. f. Maintains knowledge relevant to role in CDI, including participating in professional development and developing expertise. g. Serves as resource to CDI team members, including participation in projects and/or serving as preceptor as assigned. Clinical Documentation Specialist Minimum Required Exp: RN with 3 or more years of clinical nursing experience in an acute care setting or RHIA or RHIT with 5 or more years of inpatient (acute care) ICD 10 coding experience. Minimum Required Education: Graduated from an accredited school of nursing or Associate in Nursing or HIM. Required Certification/Licensure: RN Nurse Licensure Compact (NLC), Louisiana licensed RN and/or Mississippi licensed RN Or RHIA with CCS Certification preferred Or RHIT with CCS Certification preferred