Quality Assurance Specialist jobs at ResMed - 759 jobs
Coding Data Quality Supervisor (10K Sign-On Bonus Available)
Wellstar Health Systems, Inc. 4.6
Atlanta, GA jobs
How would you like to work in a place where your contributions and ideas are valued? A place where you can serve with compassion, pursue excellence and honor every voice? At Wellstar, our mission is simple, yet powerful: to enhance the health and well-being of every person we serve. We are proud to have become a shining example of what's possible when the brightest professionals dedicate themselves to making a difference in the healthcare industry, and in people's lives.
Work Shift
Day (United States of America) Job Summary:
The Coding Data Quality Supervisor oversees the day-to-day coding audit/analyst work queues, work assignments, personnel, and serves as a subject matter expert regarding but not limited to DRGs, APCS, ICD-10CM/PCS diagnoses and procedure codes for internal and external team members. In addition, the supervisor codes/audits accounts on a weekly basis. Provides trending feedback, applicable trending reports, and delivers education within department within areas of expertise.
The Coding Data Quality Supervisor will use their knowledge and their teams to identify potential documentation, coding and reimbursement issues and report these to the Data Quality Manager for the purpose of implementing process improvements. The Data Quality Supervisor will gather this data in a presentable format to communicate to leadership, the coding/auditing staff as well as other leaders at WellStar, as directed. The Data Quality Supervisors will make quality improvement recommendations by identifying trends pulled from their insights as well as their team's insights and participate in implementing process improvements. The Data Quality Supervisor will provide/deliver executive style written and verbal reports to include analysis of metrics within owning area to leadership.
Core Responsibilities and Essential Functions:
Team Supervision
Monitor Auditing/Analyst work queues and auditing software to ensure compliance to Coding CFB, team goals and turnaround times are met.
Assess/manages/assigns daily work/volumes. Directs and adjusts staff to volumes, PTO, vacancies, request for overtime, etc. to ensure team and CFB goals are met, seeking budgetary and managerial approval when needed.
Direct daily operational needs throughout the day for Auditing/Analyst Team. Troubleshoot issues within the team as well as internal/external customers.
Perform staff evaluations, coaching, and constructive feedback as needed. Deliver praise, positive feedback/reinforcement when applicable.
Lead productive and timely team and 1-1 meetings with staff. Deliver quality/productivity metrics on team meetings and with individual staff. Ensure all staff meet required metrics and address both positive and negative results. Assist with recognition and process improvement plans.
Manage staff time/hours/approvals within UKG.
Conduct thorough, prepared interviews and hire competent team members.
Implement process improvements within scope of work as well as conduct motivational and team building activities. Connect with staff positively and leverage individuals' strengths in an effort to use resources in the most effective manner.
Conduct sporadic or specified coding audits to ensure quality team is meeting quality metrics.
Monitors daily staff productivity.
Enforce accountability to WellStar Polices and Owning Area Policies and Procedures.
Serves as a Subject Matter Expert for, but not limited to
PSIs, Vizient methodology, IMO Code requests, 2nd opinion requests from team, other requests from internal/external customers, etc.
Investigating and responding to coding questions related to areas of expertise (i.e. inpatient, outpatient, and/or ED coding).
Manage updates for the Internal Departmental Coding Guidelines. Communicate to internal/external customers upon approval from Manager.
Review coding updates/trends from various sources and then communicates to Manager/Executive Director.
Participate in identifying trends and issues for improvements from review of records, team feedback/meetings, and/or reports.
Test software for owning areas workflows, updates, new initiatives, etc.
Maintains Reporting Profiles/Dashboard Metrics
Maintains Coder Profile monthly.
Monitors Auditing software for corrections at least weekly.
Monitors Auditing software and/or reports for validity of Productivity Worksheets at least weekly. Maintains/Updates Productivity and Quality Auditing Spreadsheets and provides deliverable reports from metrics monthly.
Creates and maintains updated instructions and tip sheets for all processes/software within scope of work for Auditors and Denial Analysts.
Provides/maintains other reports to include but not limited to: Prebill and Mortality Auditing Results, Coder focused results, etc.
Education
Oversees management of onboarding of new coders to include but not limited to attending onboarding calls, communicating quality metrics to Data Quality and Coding Managers, and ensuring onboarding processes are followed.
Onboard new Auditors/ Analysts to include contractors, if necessary.
Interpret trending errors/reports to make recommendations based on results.
Provide education within the department to include, but not limited to: trending errors, new code updates, etc.
Refer to outside sources for additional education, as needed: 3M Nosology, Coding Clinic, CMS Website.
Advocate for issues and improvement opportunities on behalf of owning area.
Codes/abstracts/audits accounts and resolve inpatient and outpatient coding denials on a weekly basis to maintain skills and assist in covering workload. Assists with Coding Analyst responsibilities as needed:
Accurately and completely assigns appropriate ICD-10 CM/PCS and/or CPT/HCPCS codes to the greatest specificity with a minimum accuracy rate.
Accurately and completely abstracts all required data into the appropriate data fields in compliance with statistical data requirements with a minimum of accuracy rate.
Accurately assigns correct APC at a minimum accuracy rate.
Meet productivity standards.
Queries physicians to further clarify code assignments, if needed.
Perform Coding Audits
Validate that the codes, abstracted data and DRGs under focused review are assigned according to official coding guidelines and supported by clinical documentation in the medical record.
Identify documentation improvement opportunities in DRG, APC, CPT, ICD-10 CM/PCS codes, POA, Point of Origin, Place of Transfer, and Discharge Disposition, and other coding and documentation elements, as needed.
Provide feedback to coding staff on areas of opportunity.
Validate adherence to WellStar Coding Policies and Procedures.
Validate adherence to WellStar Coding Query Policy.
Attend and provide notes back to the Manager for meetings: OCC, Denials, etc. Support other roles within the department. Participate as a Coding representative in meetings.
Performs other duties as assigned
Complies with all WellStar Health System policies, standards of work, and code of conduct.
Required Minimum Education:
Bachelor's Degree Health Information Management, Business or other health care related field
Required Minimum License(s) and Certification(s):
All certifications are required upon hire unless otherwise stated.
Registered Health Information Administrator (RHIA)
Registered Health Information Technician (RHIT)
Certified Coding Specialist (CCS)
Required Minimum Experience:
Minimum 5 years hospital-based inpatient/outpatient services coding experience currently meeting an accuracy in abstracting, coding and DRG assignment while meeting productivity requirements or passing score on the coding assessment provided by Coding department required.
Previous auditing in an acute care setting and supervisory or lead experience preferred and demonstrate extensive experience with DRG assignment and hospital coding of diagnosis and surgical procedures with outpatient coding experience preferred
Required Minimum Skills:
Articulate with critical thinking skills.
Ability to use Microsoft Office Suite to include but not limited to Word, PowerPoint, and Excel as well as have operational computer knowledge to manage a large team in a virtual environment which includes web conferencing, email, instant messaging, and other forms of digital technology.
EMR (electronic medical record) knowledge and navigation experience in Epic, 3M, Vizient, HealthStream, Cloudmed, and AudaPro preferred.
Excellent organizational and multi-tasking skills abilities required.
Ability to formulate oral and written data in an executive style format to leadership.
Ability to represent data professionally and appropriately within owning role to leadership.
Extensive experience with Medicare, Medicaid, and reimbursement rules and regulations on all payors.
Join us and discover the support to do more meaningful work-and enjoy a more rewarding life. Connect with the most integrated health system in Georgia, and start a future that gives you more.
$39k-55k yearly est. 1d ago
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Quality Analyst / Risk Manager
Beacon Specialized Living 4.0
Woodbridge, VA jobs
Beacon is a successful and national behavioral health company providing residential-based services and supports to children and adults with Intellectual and Developmental Disabilities, Severe Mental Illness, Autism, and high-acuity behaviors. All activities related to this position must be delivered in compliance with the company's policies and procedures, accreditation standards, state and federal licensing requirements, HCBS guidelines, and the contractual requirements of Community Mental Health Agencies and other regulatory bodies. You are expected to be aligned with the goals and mission of the organization, and to perform in accordance with our “I CARE” core values of the organization - Integrity, Compassion, Advocacy, Respect and Excellence.
*Position Summary:*
The Quality Analyst ensures execution of all Quality Department tasks within their assigned group homes, day programs and/or supported living arrangements. This role requires a high degree of collaboration with group homes, day programs and/or supported living arrangements to ensure compliance with state regulations and accreditation standards while maintaining consistency and alignment with the One Beacon philosophy. Additionally, the role involves collaboration with Quality Department leadership to address any deviations in performance beyond acceptable limits.
* *
*Primary Responsibilities:*
* Responsible for assigned schedule of in person visits to all assigned group homes/day programs
* Assigned schedule of unannounced evening home visits
* Accurately assess and document performance of assigned group homes/day programs
* Assist group home/day program staff with remediation of risks and subpar performance
* Conduct in-depth audits on all assigned group homes/day programs
* Incident management assistance, including closing incidents and monitoring quality improvements
*Education & Qualifications:*
* Highschool diploma or GED required.
* Minimum 3 years' experience in group home/day programs and/or in DSP role
*Required Information Technology (IT) Systems Skills and Proficiency:*
Beacon Specialized Living Services (BSLS) uses a variety of information technology information systems including Microsoft Office 365 including Word, Excel, Power Point, Outlook, Teams, and OneDrive. You will be responsible for learning and becoming proficient with these IT systems and others that BSLS may deploy or change in the future.
* *
*Skills and Experience:*
* Excellent organizational, analytical, and problem-solving skills.
* Strong communication and interpersonal skills. Ability to collaborate effectively with diverse teams.
* Strong computer skills utilizing various software programs and applications.
* A professional demeanor.
* Demonstrated ability to multi-task.
* Ability to work with little daily supervision.
*Physical Demands:*
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. Specific vision abilities required by this job include close vision and the ability to adjust focus. This would require the ability to lift files, open filing cabinets, and bend or stand on a stool, as necessary.
Reasonable accommodation may be made to enable qualified individuals with disabilities to perform essential functions.
*Position Type/Expected Hours of Work:*
This position will be assigned a work schedule that may occasionally include long hours and weekend work.
*Travel:*
Travel to assigned facilities and to attend meetings and other functions as requested.
*Working Environment:*
Some of the job duties will be performed from an office. However, most work will be performed at home- like settings or community facilities with the potential of exposure to infectious disease. Universal precautions are required to minimize the risk of infections. Work sites may include locations that are not barrier-free.
*AAP/EEO Statement:*
It is the policy of Beacon to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Beacon will provide reasonable accommodation for qualified individuals with disabilities.
$67k-88k yearly est. 1d ago
Supervisor , Continuous Quality Monitoring
Regal Medical Group 3.8
Los Angeles, CA jobs
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.
$70.3k-72k yearly 2d ago
Quality Analyst
Beacon Specialized Living 4.0
Mendota Heights, MN jobs
Beacon is a successful and national behavioral health company providing residential-based services and supports to children and adults with Intellectual and Developmental Disabilities, Severe Mental Illness, Autism, and high-acuity behaviors. All activities related to this position must be delivered in compliance with the company's policies and procedures, accreditation standards, state and federal licensing requirements, HCBS guidelines, and the contractual requirements of Community Mental Health Agencies and other regulatory bodies. You are expected to be aligned with the goals and mission of the organization, and to perform in accordance with our “I CARE” core values of the organization - Integrity, Compassion, Advocacy, Respect and Excellence.
Position Summary:
The Quality Analyst ensures execution of all Quality Department tasks within their assigned group homes, day programs and/or supported living arrangements. This role requires a high degree of collaboration with group homes, day programs and/or supported living arrangements to ensure compliance with state regulations and accreditation standards while maintaining consistency and alignment with the One Beacon philosophy. Additionally, the role involves collaboration with Quality Department leadership to address any deviations in performance beyond acceptable limits.
Education & Qualifications:
* Highschool diploma or GED required.
* Minimum 3 years' experience in group home/day programs and/or in DSP role
Skills and Experience:
* Excellent organizational, analytical, and problem-solving skills.
* Strong communication and interpersonal skills. Ability to collaborate effectively with diverse teams.
* Strong computer skills utilizing various software programs and applications.
* A professional demeanor.
* Demonstrated ability to multi-task.
* Ability to work with little daily supervision.
Physical Demands:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear. Specific vision abilities required by this job include close vision and the ability to adjust focus. This would require the ability to lift files, open filing cabinets, and bend or stand on a stool, as necessary.
Travel:
Travel to assigned facilities and to attend meetings and other functions as requested.
Working Environment:
Some of the job duties will be performed from an office. However, most work will be performed at home- like settings or community facilities with the potential of exposure to infectious disease. Universal precautions are required to minimize the risk of infections. Work sites may include locations that are not barrier-free.
$66k-86k yearly est. 1d ago
Quality Control Specialist
Cutting Edge Supply 4.5
Colton, CA jobs
QUALITY CONTROL
Cutting Edge Supply Company is North America's Largest Independently Owned Distributor of Ground Engaging Tools.” In operation since 1950; we have been a leader in the Heavy Equipment parts business for over 75 years. Our focus is to provide the highest quality and largest selection of wear parts for the Mining, Construction, and Material Processing.
Description
The quality control inspector performs assessment, documentation and organization tasks to support the efficiency and effectiveness of their organizations supply chain. Their duties and responsibilities include, but not limited to the following:
Position Qualification and Physical Requirements
Inspect output samples using industry-appropriate methods, such as comparing to standards, measuring dimensions and examining functionality
Experience inspection both large & small, fabricated assemblies
Experience with calipers, micrometers and other inspection tools
Position requires accurate use of a tape measure
Drive and operate a forklift
Must have experience handling big loads such as rebar, I Beams, or heavy material
Ensure that production line adheres to standards and procedures
Review blueprints and specifications to compare to produced goods
Record inspection results by completing reports, summarizing re-works and wastes and inputting data into quality database
Train production team on quality control measures to improve product excellence
Propose improvements in the production process
Monitor the use of equipment to ensure it is safe and discard or red tag any equipment that do not meet requirements
Keep measurement equipment operating accurately by following calibration requirements and scheduling repairs as needed
Must be able to lift up to 70/lbs. and use lifting devices
Must be able to communicate questions, issues, and discrepancies to supervision.
Sufficient math skills to be able to add and subtract dimensions and perform basic shop math.
Experience in heavy equipment industry a PLUS
Must be a team player
Pay Scale: Based on Ability and Experience. We offer 100% paid HMO employee insurance with PPO options available for a shared cost, dental, vision, life insurance, paid time off, 401(k) retirement savings plan that matches .50 cents on the dollar, and 5% profit sharing!
Come work with us!
Please, No Agencies
Please, No phone calls
$38k-54k yearly est. 2d ago
Typing Specialist
AFC 4.2
Carmel, IN jobs
At AFC (Automotive Finance Corporation) we fuel the entrepreneurial dream in our community. For more than 35 years, we've been committed to making dreams come true for independent car dealers. AFC's finance solutions work with more than 12,000 independent dealerships across North America freeing up cash flow to give them more time to focus on building their business. Our solutions amplify purchasing power so dealers can stock their dealership lot with vehicles their customers seek. AFC's core business complements the other business units within the OPENLANE group of companies. We connect deeply with our customers - celebrating their wins and supporting their struggles as if they were our own.
We look ahead to the bigger picture so our customers can be prepared; We stand committed to the success of our customers.
Medical, dental, and vision benefits with employer HSA contributions (US) and FSA options (US)
Immediately vested 401K (US) or RRSP (Canada) with company match
Paid Vacation, Personal, and Sick Time
Employer-paid short-term disability, long-term disability, life insurance, and AD&D (US)
Robust Employee Assistance Program
Tuition Reimbursement for eligible programs
Location: This role will be onsite at our Carmel, Indiana office. Working hours are 9am - 6pm EST.
We are seeking a Title Specialist that will act as a support partner by being the primary contact for issues regarding vehicle titles, managing all post-sale activity, verifying accuracy and ensuring compliance in any and all questionable or problematic title documents. This individual must know, practice, and ensure that company policies, procedures, and applicable state and federal laws are followed at all times. You have a self-starting mindset and can work independently with minimal supervision.
You possess strong written and verbal communication skills to effectively interact with customers and colleagues.
Request duplicate titles if and when needed according to OPENLANE policy.
Assist with keeping SOP documentation/training manuals up to date
Creates shipping labels, packages, seals, and sends titles to buyers daily via Federal Express.
Superb customer service skills, attention to detail, time management and ability to problem solve.
~ Must type 55 WPM and have strong 10-key typing skills.
~ Conflict resolution and customer service skills required.
~ Basic knowledge of Google suite applications.
High School Diploma or GED required with some college preferred.
General automotive knowledge is preferred.
$37k-66k yearly est. 23h ago
Quality Assurance Review Specialist I
Verisma Systems Inc. 3.9
Remote
Quality AssuranceReviewSpecialist I The Quality Assurance (QA) Review Specialist - performs review functions to ensure that disclosures of PHI and PI are accurate and complete and comply with client protocols, state and federal privacy laws and regulations and/or with policies and procedures regarding HIPAA, PHI and PI. This position may be performed remotely.
Duties & Responsibilities:
* Reviews authorizations and requests for records to ensure that all pertinent information is contained on these forms and the dates are valid and relevant to the release process.
* Verifies that the attached medical records correlate to the authorization and request and documentation encompasses that patient only.
* Follows all Quality Assurance policies, procedures and job aids.
* Proactively communicates with Manager or Supervisor regarding further clarification and when additional work is needed.
* Actively participates with QA Team Meeting discussions.
* Sends notifications to requestor when applicable
* Communicates with company personnel in a professional and friendly manner
* Communicates with Release of Information Specialists and Client Site Managers on issues pertaining to quality review.
* Attends and completes on time, all required training sessions provided by Verisma
* Meets accuracy standards and performance indicators established by the Company
* Performs other appropriate duties as assigned to meet the needs of the department and the Company
* Consistently live by and promote Verisma Core Values
Minimum Qualifications:
* Must be detail oriented
* HS Diploma or equivalent, additional education in Health Information is preferred
* RHIT certification, CHDA certification or the ability to take and pass the course is preferred
* Knowledge and ability to use components of Microsoft Office Suite to complete tasks and possess the ability to learn new software applications
* 2 years' experience in a professional office environment or healthcare setting, preferred with medical terminology knowledge
* Knowledge of HIPAA and state regulations related to the release of Protected Health Information, preferred
* Must be able to communicate clearly and concisely to relay information to other departments
* Must be able to work independently
$59k-86k yearly est. 19d ago
Specialist II, Clinical Quality Assurance
Arrowhead Pharmaceuticals 4.6
San Diego, CA jobs
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 AssuranceSpecialist 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
$80k-95k yearly Auto-Apply 51d ago
Specialist II, Clinical Quality Assurance
Arrowhead Pharmaceuticals, Inc. 4.6
Los Angeles, CA jobs
The Clinical Quality AssuranceSpecialist 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.
$64k-101k yearly est. Auto-Apply 56d ago
Specialist II, Clinical Quality Assurance
Arrowhead Pharmaceuticals 4.6
Los Angeles, CA jobs
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 AssuranceSpecialist 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
$80k-95k yearly 27d ago
Quality Assurance Specialist
DHD Consulting 4.3
Los Angeles, CA jobs
We are seeking a Quality AssuranceSpecialist 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
The Quality AssuranceSpecialist position is responsible for maintenance and oversight of day-to-day operations of the quality assurance/quality management program for the cytology and histology departments.
JOB RESPONSIBILITIES
ESSENTIAL FUNCTIONS:
Compile, review, and analyze data related to client concerns, QA events and corrective actions to determine areas for quality improvement.
Evaluate quality control data with appropriate department management to determine trends and issues and assist development of corrective action plans to address these issues.
Assist in review, updates and maintenance of quality assurance plans.
Support in the preparation for the quality assurance/quality management committee agenda creation and data collection with an emphasis on establishing/maintaining a standardized quality management program.
Participate in coordinating documentation for accreditation reviews.
Assists with LIS updates and training.
Assists with new test implementation.
Coordinates proficiency testing to include yearly ordering, result entry, ensure rotation through staff, and overview the process.
Provides education to staff regarding laboratory quality control programs.
Audit laboratory locations or departments for compliance with company quality policy and procedure and CLIA, CAP, State where applicable to maintain inspection readiness.
Support PathGroup's mission, vision, goals and management decisions.
Assist with development, implementation and maintenance of effective departmental QA programs and monitors.
Assist with coordination of the development, implementation, and periodic review of departmental policies and procedures.
Assist the departmental supervisors/ directors with any special projects.
Must be familiar with and abide by the Corporate Compliance Program and all corporate policies, including the Privacy and Security policies.
NON-ESSENTIAL FUNCTIONS:
Work with other departments within PathGroup and subsidiaries.
Nothing in the job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.
Other duties as assigned.
$36k-56k yearly est. 2d ago
Provider Quality Assurance Specialist (Remote NC)
Vaya Health 3.7
North Carolina jobs
LOCATION: Remote - this is a home based, virtual position that operates Monday - Friday from 8:30am - 5:00pm EST. Candidate should live in North Carolina or within 40 miles of the North Carolina border. Must be willing to travel as needed for Health and Safety (H&S) reviews.
GENERAL STATEMENT OF JOB
This position is responsible for the assessment of services delivered to members to ensure services delivered are consistent with funding requirements, best practices, provider's contracts, and federal/state rules and regulations. The person in this position monitors provider agencies and independent practitioners within the Vaya Health provider network receiving reimbursement for service provision under Medicaid, the Innovations waiver, and state funding. This position works with a team of reviewers, using monitoring tools and processes to identify instances of non-compliance that impact service/system quality. Monitoring activities may include investigations, record reviews, health and safety checks, and the provision of technical assistance. Focused monitoring may also be conducted as a result of trends identified in data reports, complaints, concerns, and incidents, or as a result of a directive by the NC DHHS to ensure quality of care of service for members. In addition, the Quality AssuranceSpecialist will monitor the implementation of interventions aimed at addressing areas of non-compliance, to ensure services are being delivered to members according to all applicable rules, regulations, and best practice models, and to ensure the health and safety of members.
ESSENTIAL JOB FUNCTIONS
The incumbent in this position serves as part of a monitoring team and will work as a part of that team to complete monitoring of network providers. Responsibilities include:
Network Performance Review and, Clinical Provider Monitoring Oversight:
Complete monitoring of behavioral health and physical health providers, including Post-Payment reviews, Block Grant Monitoring reviews, and Focused reviews based on performance report triggers as well as trends identified in data reporting, and other ad-hoc reviews as assigned. The incumbent may function as the lead reviewer or may assist, and specific tasks involved include desk top reviews, on-site reviews, reviews of member records, personnel files, provider policies, and staff and member interviews as part of the monitoring and investigation processes.
Responsible for all correspondence, reports, monitoring reports, report of findings, and plan of correction activities for any review on which he or she serves as lead reviewer. Provide technical assistance to providers during the course of reviews to assist providers in successful service delivery.
Complete and archive all correspondence, reports, monitoring reports, report of findings, and plan of correction activities for any review on which the incumbent serves as lead reviewer.
Makes appropriate referrals to external entities as needed.
Responsible for tracking the implementation of plans of correction to ensure out of compliance areas are addressed and mitigated within required timeframes.
Technical Assistance Referrals:
Support Network Providers by providing technical assistance and responding to technical assistance referrals as assigned.
Complete all associated activities to document and track technical assistance provided.
Health/Safety Checks:
Conduct announced or unannounced Health and Safety checks as needed and/or assigned to assess quality of care and ensure member Health and Safety.
Other duties as assigned.
KNOWLEDGE, SKILLS, & ABILITIES
Success in this position requires exceptional interpersonal skills, and highly effective communication ability. A high level of diplomacy and discretion is required to effectively negotiate and resolve issues. In addition, the person in this position must have:
Knowledge of state and federal rules, requirements and practices related to the service continuum in North Carolina.
Knowledge of policy and procedure is essential related to monitoring plans of correction and resolution.
Ability to analyze and interpret policy and procedural guidelines.
Problem solving and conflict resolution skills are essential.
Excellent computer skills; proficiency in Microsoft Office Suite; and experience creating documents, forms, and graphs.
Skilled in organizing workflow and strong detail orientation.
Excellent verbal and written skills.
EDUCATION & EXPERIENCE REQUIREMENTS
Bachelor's degree in a Human Service field (such as Psychology, Social Work, etc.) required. Master's degree preferred. Two years of experience in the field of mental health, intellectual and developmental disabilities, or substance use disorders is required.
Meeting the criteria of being a North Carolina Qualified professional in 10A NCAC 27G .0104 is preferred.
Licensure/Certification Required:
CLEAR/NCIT Basic Certified Investigator (certification should be completed within the first 9 months of employment)
Preferred work experience:
Three or more years of experience in the field of mental health, intellectual and developmental disabilities, or substance use disorders is preferred.
Meeting the criteria of being a North Carolina Qualified professional in 10A NCAC 27G .0104 is preferred.
PHYSICAL REQUIREMENTS
Close visual acuity to perform activities such as preparation and analysis of documents; viewing a computer terminal; and extensive reading.
Physical activity in this position includes crouching, reaching, walking, talking, hearing and repetitive motion of hands, wrists and fingers.
Sedentary work with lifting requirements up to 10 pounds, sitting for extended periods of time.
Mental concentration is required in all aspects of work.
RESIDENCY REQUIREMENT: The person in this position should live in North Carolina or within 40 miles of the North Carolina border.
SALARY: Depending on qualifications & experience of candidate. This position is exempt and is not eligible for overtime compensation.
DEADLINE FOR APPLICATION: Open until filled
APPLY: Vaya Health accepts online applications in our Career Center, please visit ******************************************
Vaya Health is an equal opportunity employer.
$35k-48k yearly est. Auto-Apply 14d ago
Provider Quality Assurance Specialist (Remote NC)
Vaya Health 3.7
Remote
LOCATION: Remote - this is a home based, virtual position that operates Monday - Friday from 8:30am - 5:00pm EST. Candidate should live in North Carolina or within 40 miles of the North Carolina border. Must be willing to travel as needed for Health and Safety (H&S) reviews.
GENERAL STATEMENT OF JOB
This position is responsible for the assessment of services delivered to members to ensure services delivered are consistent with funding requirements, best practices, provider's contracts, and federal/state rules and regulations. The person in this position monitors provider agencies and independent practitioners within the Vaya Health provider network receiving reimbursement for service provision under Medicaid, the Innovations waiver, and state funding. This position works with a team of reviewers, using monitoring tools and processes to identify instances of non-compliance that impact service/system quality. Monitoring activities may include investigations, record reviews, health and safety checks, and the provision of technical assistance. Focused monitoring may also be conducted as a result of trends identified in data reports, complaints, concerns, and incidents, or as a result of a directive by the NC DHHS to ensure quality of care of service for members. In addition, the Quality AssuranceSpecialist will monitor the implementation of interventions aimed at addressing areas of non-compliance, to ensure services are being delivered to members according to all applicable rules, regulations, and best practice models, and to ensure the health and safety of members.
ESSENTIAL JOB FUNCTIONS
The incumbent in this position serves as part of a monitoring team and will work as a part of that team to complete monitoring of network providers. Responsibilities include:
Network Performance Review and, Clinical Provider Monitoring Oversight:
Complete monitoring of behavioral health and physical health providers, including Post-Payment reviews, Block Grant Monitoring reviews, and Focused reviews based on performance report triggers as well as trends identified in data reporting, and other ad-hoc reviews as assigned. The incumbent may function as the lead reviewer or may assist, and specific tasks involved include desk top reviews, on-site reviews, reviews of member records, personnel files, provider policies, and staff and member interviews as part of the monitoring and investigation processes.
Responsible for all correspondence, reports, monitoring reports, report of findings, and plan of correction activities for any review on which he or she serves as lead reviewer. Provide technical assistance to providers during the course of reviews to assist providers in successful service delivery.
Complete and archive all correspondence, reports, monitoring reports, report of findings, and plan of correction activities for any review on which the incumbent serves as lead reviewer.
Makes appropriate referrals to external entities as needed.
Responsible for tracking the implementation of plans of correction to ensure out of compliance areas are addressed and mitigated within required timeframes.
Technical Assistance Referrals:
Support Network Providers by providing technical assistance and responding to technical assistance referrals as assigned.
Complete all associated activities to document and track technical assistance provided.
Health/Safety Checks:
Conduct announced or unannounced Health and Safety checks as needed and/or assigned to assess quality of care and ensure member Health and Safety.
Other duties as assigned.
KNOWLEDGE, SKILLS, & ABILITIES
Success in this position requires exceptional interpersonal skills, and highly effective communication ability. A high level of diplomacy and discretion is required to effectively negotiate and resolve issues. In addition, the person in this position must have:
Knowledge of state and federal rules, requirements and practices related to the service continuum in North Carolina.
Knowledge of policy and procedure is essential related to monitoring plans of correction and resolution.
Ability to analyze and interpret policy and procedural guidelines.
Problem solving and conflict resolution skills are essential.
Excellent computer skills; proficiency in Microsoft Office Suite; and experience creating documents, forms, and graphs.
Skilled in organizing workflow and strong detail orientation.
Excellent verbal and written skills.
EDUCATION & EXPERIENCE REQUIREMENTS
Bachelor's degree in a Human Service field (such as Psychology, Social Work, etc.) required. Master's degree preferred. Two years of experience in the field of mental health, intellectual and developmental disabilities, or substance use disorders is required.
Meeting the criteria of being a North Carolina Qualified professional in 10A NCAC 27G .0104 is preferred.
Licensure/Certification Required:
CLEAR/NCIT Basic Certified Investigator (certification should be completed within the first 9 months of employment)
Preferred work experience:
Three or more years of experience in the field of mental health, intellectual and developmental disabilities, or substance use disorders is preferred.
Meeting the criteria of being a North Carolina Qualified professional in 10A NCAC 27G .0104 is preferred.
PHYSICAL REQUIREMENTS
Close visual acuity to perform activities such as preparation and analysis of documents; viewing a computer terminal; and extensive reading.
Physical activity in this position includes crouching, reaching, walking, talking, hearing and repetitive motion of hands, wrists and fingers.
Sedentary work with lifting requirements up to 10 pounds, sitting for extended periods of time.
Mental concentration is required in all aspects of work.
RESIDENCY REQUIREMENT: The person in this position should live in North Carolina or within 40 miles of the North Carolina border.
SALARY: Depending on qualifications & experience of candidate. This position is exempt and is not eligible for overtime compensation.
DEADLINE FOR APPLICATION: Open until filled
APPLY: Vaya Health accepts online applications in our Career Center, please visit ******************************************
Vaya Health is an equal opportunity employer.
Job DescriptionAmity Foundation, internationally acclaimed teaching, and therapeutic community is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as a Quality AssuranceSpecialist. This groundbreaking opportunity not only will allow you to work with our prison programs to help the inmate population but will also enhance your training and experience in the field.
About Amity:Amity Foundation is a safe place where people can change in an environment that fosters trust; where new values can be formed; responsibility developed, and lasting relationships built. Amity is dedicated to the inclusion and habilitation of people marginalized by addiction, homelessness, trauma, criminality, incarceration, poverty, racism, sexism, and violence. Amity is committed to research, development implementation, and dissemination of information regarding community building.
Remembrance, Resolution, Reconciliation, Restoration, Renewal
About the Position:The Quality AssuranceSpecialist will ensure that Amity Foundation complies with its external/internal regulatory and legal requirements as well as policies, procedures, and bylaws. The Quality AssuranceSpecialist will assist and provide support to Los Angeles, Vista and CTR campuses as well as taking a supporting role with CARF (Commission on Accreditation of Rehabilitation Facilities) and other accreditation means. What You Will Do:
Monitor compliance and ensure that contract compliance is embedded throughout Amity programs state-wide.
Reviewing CARF standards and identifying updates and changes. Translate standards and evidence of compliance into practical behaviors or practice.
Identify gaps in programs self-reported vs actual compliance with state, federal and accrediting agency standards.
Take a supporting role in preparing and monitoring certification and recertification processes.
Coordinate Continuing Quality Assurance committees and sub-committees across all campuses.
Participate in regular status meetings with compliance department to conduct on-going assessments of survey readiness, assist with corrective action plans, implementation, and evaluations.
Support Continuous Quality Improvement process with continuous implementation of quality improvement.
Maintain updated CARF, ADA, regulatory knowledge.
Create and monitor output measurement and other necessary reports as it pertains to compliance and accreditation.
Internal and external audit preparation and support. Spot checking and file reviews. Generating audit reports, findings and creating corrective action plans and monitoring progress.
Travel to Amity campuses across CA and AZ.
Attending compliance conferences as needed to stay abreast of changes and expand knowledge.
Other duties as assigned.
What You Will Bring:
Required:
One year of paraprofessional experience. Bachelor of Science Degree in Social Service or related field.
Preferred:
Experience providing services to low-income individuals in a community setting with criminal justice, homeless or at-risk populations.
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) and widely supported internet browsers.
The ability to communicate with and relate to a diverse group of people including students, community, and other staff.
Knowledge of homeless services and resources is preferred
Excellent organizational skills and attention to detail.
Excellent written and verbal communication skills.
Extensive knowledge of office management systems and procedures.
Ability to maintain confidential information.
Ability to operate general office equipment.
What We Offer:
100% Employer-Sponsored HMO plan.
PPO Medical, Dental, Vision.
Paid vacation, sick time, & 11 holidays.
401K, HSA, & Life insurance programs.
Community-oriented workplace.
An organization committed to community action & social justice.
$44k-66k yearly est. 21d ago
Quality Assurance Specialist
DHD Consulting 4.3
Shelbyville, TN jobs
is responsible for reviewing processes and identifying areas for improvement to enhance quality. The Quality AssuranceSpecialist is responsible for understanding customer expectations, establishing quality standards, and developing quality management processes. Ultimately, the role of the Quality AssuranceSpecialist is to ensure that products meet all required requirements before reaching the customer.
Key Responsibilities
-Perform regular inspections and audits, document findings, and support corrective and preventive action plans.
-Analyze quality trends and data to suggest improvements and solutions for process optimization.
-Support training for all employees to ensure they are familiar with quality protocols, particularly
recommending new or recurring training areas.
-Manage and resolve quality-related issues, providing technical support within the Quality Department as well as across departments.
-Provide support for all quality-related audits from external and regulatory agencies.
-Regularly inspect documentation, facilities, and customer requirements for compliance.
-Resolve routine quality issues and diagnose manufacturing-related problems.
-Maintain and update instrument calibration records accordingly.
-Reporting Structure Reports to: Quality Management Group Manager
Professional Experience and Qualifications
-Bachelor's degree in chemistry or a related field
-Bilingual in Korean and English
-Proficient in Microsoft Office (PowerPoint, Excel, Word)
Qualifications
- Education: Bachelor's degree or higher
- Major: No specific requirement
- Experience: 8 years or less
- English proficiency (Business Level or higher)
Preferred Qualifications:
-Quality AssuranceSpecialist or similar experience
-Relevant training and/or quality engineer certification
-IATF/ISO Internal Auditor Certification (VDA6.3)
-Personal and Professional Qualifications
-Strong detail-oriented and results-oriented approach
-Highly reliable and trustworthy
-Excellent oral and written communication skills
-Excellent mathematical skills with proficiency in data analysis and statistical methods
-Thorough knowledge of quality assurance methodologies and standards
-Working knowledge of quality assurance tools, methods, and concepts (SPC, IATF16949, MSA, etc.)
Amity Foundation, internationally acclaimed teaching, and therapeutic community is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as a Quality AssuranceSpecialist. This groundbreaking opportunity not only will allow you to work with our prison programs to help the inmate population but will also enhance your training and experience in the field.
About Amity:Amity Foundation is a safe place where people can change in an environment that fosters trust; where new values can be formed; responsibility developed, and lasting relationships built. Amity is dedicated to the inclusion and habilitation of people marginalized by addiction, homelessness, trauma, criminality, incarceration, poverty, racism, sexism, and violence. Amity is committed to research, development implementation, and dissemination of information regarding community building.
Remembrance, Resolution, Reconciliation, Restoration, Renewal
About the Position:The Quality AssuranceSpecialist will ensure that Amity Foundation complies with its external/internal regulatory and legal requirements as well as policies, procedures, and bylaws. The Quality AssuranceSpecialist will assist and provide support to Los Angeles, Vista and CTR campuses as well as taking a supporting role with CARF (Commission on Accreditation of Rehabilitation Facilities) and other accreditation means. What You Will Do:
Monitor compliance and ensure that contract compliance is embedded throughout Amity programs state-wide.
Reviewing CARF standards and identifying updates and changes. Translate standards and evidence of compliance into practical behaviors or practice.
Identify gaps in programs self-reported vs actual compliance with state, federal and accrediting agency standards.
Take a supporting role in preparing and monitoring certification and recertification processes.
Coordinate Continuing Quality Assurance committees and sub-committees across all campuses.
Participate in regular status meetings with compliance department to conduct on-going assessments of survey readiness, assist with corrective action plans, implementation, and evaluations.
Support Continuous Quality Improvement process with continuous implementation of quality improvement.
Maintain updated CARF, ADA, regulatory knowledge.
Create and monitor output measurement and other necessary reports as it pertains to compliance and accreditation.
Internal and external audit preparation and support. Spot checking and file reviews. Generating audit reports, findings and creating corrective action plans and monitoring progress.
Travel to Amity campuses across CA and AZ.
Attending compliance conferences as needed to stay abreast of changes and expand knowledge.
Other duties as assigned.
What You Will Bring:
Required:
One year of paraprofessional experience. Bachelor of Science Degree in Social Service or related field.
Preferred:
Experience providing services to low-income individuals in a community setting with criminal justice, homeless or at-risk populations.
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Outlook) and widely supported internet browsers.
The ability to communicate with and relate to a diverse group of people including students, community, and other staff.
Knowledge of homeless services and resources is preferred
Excellent organizational skills and attention to detail.
Excellent written and verbal communication skills.
Extensive knowledge of office management systems and procedures.
Ability to maintain confidential information.
Ability to operate general office equipment.
What We Offer:
100% Employer-Sponsored HMO plan.
PPO Medical, Dental, Vision.
Paid vacation, sick time, & 11 holidays.
401K, HSA, & Life insurance programs.
Community-oriented workplace.
An organization committed to community action & social justice.
$23 - $25 an hour
$23-25 hourly Auto-Apply 19d ago
Quality Coordinator
DCI Donor Services 3.6
Nashville, TN jobs
DCI Donor Services
New Mexico Donor Services (NMDS) is looking for a dynamic and enthusiastic team member to join us to save lives!! Our mission at NMDS is to save lives through organ and tissue donation, and we want professionals on our team that will embrace this important work!! We are specifically wanting someone to join our team as Quality Coordinator. The Quality Coordinator oversees the assembly, review and maintenance of organ donor records to maintain integrity, compliance and security of donor information. This role ensures internal and external reporting is completed in a timely manner to meet compliance requirements to state, regulatory and accrediting agencies.
COMPANY OVERVIEW AND MISSION
For over four decades, DCI Donor Services has been a leader in working to end the transplant waiting list. Our unique approach to service allows for nationwide donation, transplantation, and distribution of organs and tissues while maintaining close ties to our local communities.
DCI Donor Services operates three organ procurement/tissue recovery organizations: New Mexico Donor Services, Sierra Donor Services, and Tennessee Donor Services. We also maximize the gift of life through the DCI Donor Services Tissue Bank and Sierra Donor Services Eye Bank.
Our performance is measured by the way we serve donor families and recipients. To be successful in this endeavor is our ultimate mission. By mobili
We are committed to diversity, equity, and inclusion. With the help of our employee-led strategy team, we will ensure that all communities feel welcome and safe with us because we are a model for fairness, belonging, and forward thinking.
Key responsibilities this position will perform include:
Responsible for obtaining and reviewing all culture results & assists in reporting of culture results. Differentiates between potential infections or culture contamination. Reports results within 24 hours to appropriate transplant centers and governing bodies.
Responsible for obtaining, reviewing and reporting autopsy results for both organ donors. Ability to review the results to assess for cause of death and incidental findings necessary to report to recipient transplant centers.
Responsible for notifying all transplant centers and other applicable agencies when there is a reportable finding in the autopsy.
Responsible for obtaining autopsy results for tissue donors and providing to the Quality Assurance Team for dissemination to processors.
Obtains recipient follow up for all donor cases from appropriate transplant centers.
Responsible for working with Exam Works to provide timely organ/donor reimbursement to hospitals. Works closely with the Clinical Review Coordinator to accurately send redacted donor records to the contact at Exam Works.
Monitors status of required UNET Data Reporting Deceased Donor Record (DDR), Donor Disposition, PTRs, etc.
May assist Clinical Review Coordinator with elements of organ donor chart review.
If applicable, provides seven day a week coverage for reportable events such as culture results, autopsies, etc.
Ability to recognize confirmed reportable diseases required to report to applicable state agencies.
Schedules and provides monthly agenda for Quality Department meeting and completes minutes.
Responsible for maintaining logs for offsite storage of records and for communication with off-site storage facility personnel such as: requesting, returning, and adding new items (labeled boxes) to be stored off-site.
Recognizes and reports trends and opportunities for process improvement related to donor records and OPO statistics to quality management.
Maintains open verbal and written communication with DCIDS and location Quality Department teams and all other applicable DCIDS departments as it relates to job functions and tasks.
Acts as a role model for DCIDS and the DCIDS Quality Departments by supporting, reinforcing, and exhibiting behaviors consistent with the DCIDS core values; selfless, hardworking, passionate, and dependable.
Performs other duties as assigned.
The ideal candidate will have:
Associates degree or equivalent. Bachelors degree in related healthcare preferred.
1 year prior medical records or medical related job experience
Working knowledge of computers and basic data entry skills required.
We offer a competitive compensation package including:
Up to 176 hours (22, 8-hour days) of PTO your first year
Up to 72 hours (9, 8-hour days) of Sick Time your first year
Two Medical Plans (your choice of a PPO or HDHP), Dental, and Vision Coverage
403(b) plan with matching contribution
Company provided term life, AD&D, and long-term disability insurance
Wellness Program
Supplemental insurance benefits such as accident coverage and short-term disability
Discounts on home/auto/renter/pet insurance
Cell phone discounts through Verizon
**New employees must have their first dose of the COVID-19 vaccine by their potential start date or be able to supply proof of vaccination.**
You will receive a confirmation e-mail upon successful submission of your application. The next step of the selection process will be to complete a video screening. Instructions to complete the video screening will be contained in the confirmation e-mail. Please note - you must complete the video screening within 5 days from submission of your application to be considered for the position.
DCIDS is an EOE/AA employer M/F/Vet/Disability.
PIb60b3871b8c7-31181-39209031
$51k-72k yearly est. 7d ago
Clinical Documentation Specialist
FMOL Health System 3.6
Los Angeles, CA jobs
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
$42k-59k yearly est. 15d ago
(CW) QA Associate
Biomarin Pharmaceutical 4.6
Novato, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
This is a Contract role-**Onsite 5 days per week in Novato, CA. Possibility of working offsite when fully trained***
QA Associate
Description:
This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviors and understand the principles to drive a culture of continuous improvement building a High-Performance Organization.
General QA Associate Responsibilities:
●Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections.
●Provide Quality input to Deviations ensuring scope of record is clear and investigations are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable.
●Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply, Distribution, Maintenance, Metrology, and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimizing impact to Lot Release operations on site.
●Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.