Quality Assurance Specialist jobs at IEHP

JOB SUMMARY: Support the Compliance Department for Imperial Health Plan of California, Inc. / Imperial Health Holdings Medical Group. May support the NCQA Accreditation Program and oversight processes, CMS compliance, medicare part D& C audits and accreditation best practices and ongoing training activities. ESSENTIAL JOB FUNCTIONS: Serve as the UM Compliance Specialist with Delegated Health Plan contacts for reporting deliverables. Track due dates and deliverables. Assist UM Lead Compliance Specialist with development of policies and procedures, program plans, and work plans for IHP/IHHMG. Assist in the organization of internal and external audits, compile requested documents for UM IHP/IHHMG regulatory audits, manage audit repositories and maintain master audit dashboard. Track due dates and deliverables. Schedule meetings for UM projects and/or regulatory audits. Assist in developing presentations/reports for UM. Acts as a resource to staff, providers and/or members for UM program information. Adheres to payroll policies and properly uses a timekeeping system with minimal manual changes. Maintains regular and consistent attendance. Adheres to Compliance Plan and HIPAA regulations. Other duties as assigned to support regulatory compliance. MARGINAL JOB FUNCTIONS: Takes on special projects as needed and requested. Performs other duties as assigned. BEHAVIORAL EXPECTATIONS: Continuous Learning: Attends staff meetings as required. Attends appropriate training, seminars and workshops as required. Customer Focus: Maintains client/customer confidentiality and privacy in accordance with HIPPA regulations and IMAS's Standards of Conduct. Fosters appropriate communication and relations with Supervisor, co-workers, and other staff. Quality/Process Improvement/Safety Reports issues of security, health and/or safety to appropriate supervisor as soon as practicable. Supports and demonstrates safety throughout all duties performed. Follows established policies and procedures and understands and complies with all regulators standards set forth by governing entities. POSITION REQUIREMENTS: Regulatory compliance CMS NCQA Claims EDUCATION/EXPERIENCE: High school graduate or equivalent. Bachelor's Degree or equivalent combination of education and technical experience can substitute in lieu of degree.

Remote - Clinical Documentation Specialist Inpatient Coding Full Time Status Day Shift Pay: $60,382.40 - 96,616.00 / year Candidates residing in the following states will be considered for remote employment: Alabama, Colorado, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Minnesota, Missouri, Mississippi, Nebraska, North Carolina, Oklahoma, Texas, Utah, and Virginia. Remote work will not be permitted from any other state at this time. This position provides support, consultation, compliance to evidence-based care, and clinical documentation practices. Facilitates and drives improvements in the clinical performance initiatives and helps to maintain regulatory compliant documentation. Performance relies on general nursing/clinical knowledge, including pathophysiology, pharmacology, regulatory requirements and ACDIS professional guidelines. Advanced communication and education to a broad audience including medical staff, patients, clinical departments in the form of specific chart reviews and broad presentation/education. Collaborates regarding clinical and coding knowledge with key stakeholders within the organization. Responsibilities include concurrent review of the clinical documentation to obtain the most accurate and complete physician documentation that appropriately supports the severity of illness, risk of mortality and proper reimbursement. This position works under the supervision of the Manager and is employed by Mosaic Health Systems. Conducts initial concurrent review and ongoing re-reviews of clinical documentation for all selected admissions to initiate the tracking process and document findings. Assigns and updates working DRG for encounters, reviewing in a timely manner and documenting thoroughly in clinical documentation improvement system. Identifies need to clarify documentation in records and initiates communication with physician or physician extender utilizing the appropriate query tools in order to capture the documentation in the medical record that accurately supports the patient's severity of illness. Utilizes monitoring tools to track the progress of the concurrent review program, interprets tracking information and reports findings. Provides information and education as necessary to physicians and ancillary staff. This includes participation on work teams. Other duties as assigned All required education is a minimum requirement. Higher levels of education are acceptable. Associate's Degree nursing required. Bachelor's Degree nursing preferred. RN - Registered Nurse - State Licensure And/Or Compact State Licensure in state, depending upon designated work location is required. AND CCDS Certification - Certificated Clinical Documentation Specialist to be obtained within two years of hire is required. OR CDIP Certification - Certified Documentation Information Practitioner to be obtained within two years of hire required. Certificated Clinical Documentation Specialist to be obtained within two years of hire is required; or Certified Documentation Information Practitioner to be obtained within two years of hire required. 3 years of clinical experience in an ICU/Critical Care acute care setting is required. 2 years of clinical documentation specialist experience.

Quality AssuranceReview Specialist 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

Here at Hologic it is our purpose to enable healthier lives everywhere, every day. We are driven by our passion to become the global champion for women's health. We achieve this by fulfilling our promise to bring The Science of Sure to life. The Post Market Quality Assurance (QA) team plays a critical role in safeguarding patient safety and ensuring regulatory compliance across global markets for Hologic Molecular Diagnostic products. Think this role is for you? As a Quality Assurance Specialist 1 under the Post-Market QA team, you will play a key role in ensuring the safety, effectiveness, and regulatory compliance of medical devices after release. You will be responsible for monitoring and facilitating post-market complaints, ensuring compliance with applicable industry regulations, standards, and company policy. Success in this role requires strong analytical skills, attention to detail, and effective collaboration with cross-functional teams to resolve issues of limited complexity and drive continuous improvement. Key Outcomes Complaint handling and investigation Receive, document, and process product complaints in compliance with applicable regulatory requirements and company standard operating procedures (SOPs). Conduct initial assessment of complaints. Regulatory reporting Identify and escalate potential adverse events to QA management. Support preparation and submission of regulatory reports according to global regulatory requirements under supervision of Senior QA Specialists or management. Ensure post-market activities are compliant. Data analysis and trending Assist with complaint metrics and basic trend analysis. Perform complaint-related queries as needed. Audit and inspection support Support internal and external audits related to post-market surveillance and complaint handling as needed. Maintain accurate and audit-ready documentation. Training and process development Contribute to the development and improvement of SOPs, and other materials related to post-market quality assurance under the supervision of Senior QA Specialists or management. Do you have what it takes? You are a good communicator, have impeccable attention to detail, and strong organizational and documentation skills. You work well in a cross-functional team environment, can work independently, and have a proactive mindset. You have strong analytical and problem-solving skills and are comfortable presenting data. Additional qualifications and information Bachelor's degree in Engineering, Quality, Life Sciences, or related field, or equivalent experience. 0-2 years of experience in post-market quality assurance within the medical device industry is highly preferred. Knowledge of post-market surveillance, complaint handling, and regulatory reporting requirements (e.g., ISO 13485, FDA 21, CFR 820, EU, MDR). Certification in Quality or Regulatory (ASQ, RAPS) is a plus ---- The annualized base salary range for this role is $70,500 - $71,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand. Agency And Third Party Recruiter Notice Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-EK1

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Assures that suppliers and raw materials are suitable for their intended use in clinical and commercial manufacturing. Responsible for compliance with regulations, procedures, and systems that govern the supplier approval, material qualification programs, along with ongoing supplier/material compliance. Supports client audits and regulatory inspections as needed. Support vendor complaint generation and resolution, along with evaluation and internal processing of vendor changes Responsibilities: Contribute and adhere to Supplier Quality Management systems and compliance activities. Participate in Improvement initiatives, within the SQM functional area. Under moderate supervision, complete multiple assigned functions in the SQM Compliance Area: Assist Supplier Quality Management to ensure Suppliers, Materials/Services are suitable for their intended use by conducting routine evaluations (desk/remote/onsite/for-cause audits, annual assessments, etc.). Auditor certification required (ex. ASQ or equivalent) Assist with Quality Agreement assessments and revisions through supplier communications, to ensure documents are current and compliant. Work with internal department personnel (ex. MSAT, QA/QCRM, Manufacturing, AFS, PD, etc.) to onboard new suppliers and materials. Assist with client project material qualification plans through review of the listed materials, alignment with ETQ material profiles, participation in project meetings, review and upload of material qualification data in EtQ, approval of material profiles, and periodic review of material profiles associated with assigned projects. Support and process supplier complaints (SCNs) and Vendor Change Notifications (VCNs). Support SQM related Deviations, CAPAs, and Change Controls as appropriate. Requirements: BS/BA +3 or >5 years relevant experience or combination of education and experience within a QA or cGMP environment in biopharmaceuticals or equivalent, including previous pharmaceutical supplier quality experience. Auditor certification or demonstrated supplier/internal auditing experience. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedures. Ability to effectively present information and respond to questions from staff, colleagues, managers, and clients. Ability to read, analyze, and author complex documentation. Ability to travel domestically and internationally, where needed, for supplier audits. Ability to travel ~10-15% for onsite supplier audits and site-to-site meetings where applicable. Salary Range: $74,000 - $102,300 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, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit ********************* KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. 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.

Applied Intuition is the vehicle intelligence company that accelerates the global adoption of safe, AI-driven machines. Founded in 2017 and now valued at $15 billion following its recent Series F funding round, Applied Intuition delivers the Vehicle OS, Self-Driving System, and toolchain to help customers build intelligent vehicles and shorten time to market. 18 of the top 20 global automakers and major programs across the Department of Defense trust Applied Intuition's solutions to deliver vehicle intelligence. Applied Intuition services the automotive, defense, trucking, construction, mining, and agriculture industries and is headquartered in Mountain View, CA, with offices in Washington, D.C., San Diego, CA, Ft. Walton Beach, FL, Ann Arbor, MI, London, Stuttgart, Munich, Stockholm, Bangalore, Seoul, and Tokyo. Learn more at applied.co. We are an in-office company, and our expectation is that employees primarily work from their Applied Intuition office 5 days a week. However, we also recognize the importance of flexibility and trust our employees to manage their schedules responsibly. This may include occasional remote work, starting the day with morning meetings from home before heading to the office, or leaving earlier when needed to accommodate family commitments. (Note: For EpiSci job openings, fully remote work will be considered by exception.) Meet our software engineers! Meet some of our software engineers who are shaping the future of autonomy and delivering world-class solutions helping customers shorten time to market. Hear about what brought them to Applied Intuition, what's kept them interested, and their advice to potential candidates. About the role (We are hiring for all levels of experience.) We're looking for an experienced and safety-minded QA specialist to drive the stability and quality of our product. On this team, you'll be working on developing cutting-edge solutions for autonomous vehicles in the mining industry, where safety is our first concern. You'll be working closely with engineering and with the testing team, deeply integrating quality processes into our development cycles. You'll work across the entire stack on hardware and software, and also work directly with our customers to ensure our releases are safe for deployment. The ideal teammate here can bring the culture of safety and quality to our team, while speeding up our product development. At Applied Intuition, you will: Design QA processes that deeply integrate with our engineering program to balance both speed and quality Connect engineering teams with testing teams to ensure a healthy feedback loop on both feature tests and master testing Collaborate closely with engineers, product managers, and engineering managers to build detailed test programs for our products that push the frontier of AV software development Work with simulation and CICD to build automated test pipelines into our test plans Monitor and track the health of the system, working with triage engineers to fix bugs; generate reports for releases Define QA metrics on system and organizational health, tracking metrics on number of bugs and escalation times Own the quality of the product and serve as the last line of defense We're looking for someone who has: B.S. in Computer Science, Software, Electrical, Physics, Mathematics, or similar engineering field Experience testing physical software systems such as vehicles, headsets, mobile devices, embedded systems, etc. Experience working in or designing programs with limited physical testing volume Experience working in a quality or testing organization as a test engineer, QA engineer, triage engineer, or similar Strong communication and organizational skills A culture of quality and safety first, but also able to enable engineering speed Nice to have: Prior experience with either AV simulation or vehicle simulation Ability to triage and debug issues with an autonomous vehicle in either software or hardware Hands-on experience testing, troubleshooting, or debugging complex software systems Compensation at Applied Intuition for eligible roles includes base salary, equity, and benefits. Base salary is a single component of the total compensation package, which may also include equity in the form of options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment. Applied Intuition pay ranges reflect the minimum and maximum intended target base salary for new hire salaries for the position. The actual base salary offered to a successful candidate will additionally be influenced by a variety of factors including experience, credentials & certifications, educational attainment, skill level requirements, interview performance, and the level and scope of the position. Please reference the job posting's subtitle for where this position will be located. For pay transparency purposes, the base salary range for this full-time position in the location listed is: $110,000 - $170,000 USD annually. Don't meet every single requirement? If you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. Applied Intuition is an equal opportunity employer and federal contractor or subcontractor. Consequently, the parties agree that, as applicable, they will abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a) and that these laws are incorporated herein by reference. These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. These regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability. The parties also agree that, as applicable, they will abide by the requirements of Executive Order 13496 (29 CFR Part 471, Appendix A to Subpart A), relating to the notice of employee rights under federal labor laws.

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

Requirements Applicants must possess a Bachelor's or Master's degree in Social Work or a related field; two years of experience in human services (preferably in the field of developmental disabilities); knowledge of basic needs and philosophy in working with individuals with developmental disabilities; excellent written, verbal, and interpersonal communications skills; ability to conduct research, analyze data, and compile and disseminate information; knowledge of various laws and regulations including Title 17, Title 22, federal regulations for ICF, and California Codes of Regulations; knowledge of “vendorization” and quality assurance policies and procedures is preferred. Other requirements and qualifications apply. EQUAL OPPORTUNITY EMPLOYER

Job Purpose/Summary This position will be responsible for supporting and assisting with the management and maintenance of the site-wide quality program, as well as the EHS program. The program is designed to ensure continuous measurement and improvement in site quality, compliance and overal performance. This position is responsible for overseeing key quality program elements such as, document control, internal facility audits, data and report audits, deviation, investigations, CAPA and general facility and/or study events. The employee will work to ensure the consistency, reproducibility, quality and integrity of operations in line with Crown programs. The position will employ effective tools to support risk mitigation of quality deviations and to respond to quality deviations implementing measures to correct and prevent future occurrences. The position will also be responsible for ensuring compliance to applicable laws, guidelines and regulations governing the sites operations. The success of the role will be measured by continuous improvements in site quality, compliance and efficiency of operation, meeting or exceeding client expectations and corporate goals and objectives. Essential Functions/Responsibilities * Support and assist with the management and maintenance of the site-wide quality program, including GLP/GCLP/ISO9001/CLIA/CAP requirements for pre-clinical and clinical operations, as applicable. * Conduct routine internal audits of the animal vivarium, in-vitro and biomarker laboratories * Manage document control in EQMS * Assist with the site training program. * Provide support for internal/external complaint and deviation investigations. * Support study directors to develop Corrective Action Preventive Action (CAPA) plans. * Support the various site continued improvement efforts. * Lead site internal audits to ensure compliance to QMS * Support client audit and supplier qualification program. * Represent QAU on the site EHS (Environment, Health and Safety) team * Monitor site key performance indicator (KPI) and provide reports for management review * Actively contribute to the success of the overall QA team and the site as a whole. Minimum Requirements * Requires a Bachelor degree in a technical field, or equivalent combination of academic and work experience. * Requires 2+ years of auditing and document control within a regulated environment * Able to interpret analytical data to support decision-making * Able to communicate in a clear, coherent and concise manner (verbal and written communication) * Willing and able to work independently and in a team environment to efficiently meet assigned timelines * Comfortable using computers, including a working knowledge of Microsoft Office programs, e-mail, and Internet * Excellent interpersonal, organizational and time-management skills * Able to multi-task with a high degree of professionalism and diplomacy Preferred Requirements * Laboratory working experience in regulated environment is preferred * Experience working with an EHS is team preferred * Experience with AAALAC/IACUC is preferred * Experience with Veeva Vault e-QMS and IDBS ELN systems is preferred The California salary range for this position is: $78,795.00 - $92,700.00 This salary (or salary range) is merely an estimate and may vary based on an applicant's skills and prior relevant experience. Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

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

Amity Foundation, an internationally acclaimed Teaching, and Therapeutic Community is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as an ECM- Quality Assurance Specialist. This groundbreaking opportunity will allow you to work with our prison and re-entry programs helping the community and 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 What You Will do: Regularly review ECM student files to ensure compliance with auditing standards set by local, state, and federal funding regulations. Collect, enter, and manage program data, ensuring accuracy and integrity of student records. Generate reports and submit data as required to support program evaluation and funding requirements. Regularly review services in the electronic health record system for possible errors, duplications, or other issues that could cause claim denials in an effort to make the reporting for month end billing seamless and to reduce the potential of claim denials. Prepare reports from the electronic health record system for the timely submission of claims, working closely with the accounting department to ensure proper reimbursement for services. Assist in the development and implementation of quality assurance policies and procedures. Maintain a thorough understanding of agency systems and policies to effectively support ECM program staff and contribute to quality improvement initiatives. Interface with contracted Managed Care Plan (MCP) electronic systems, including for client information sharing and service claiming. Manage receipt of student information files (MIF) from MCPs and provide MCPs with information regarding outreach and engagement status. Ensure complete client charts within agency's Electronic Health Record (EHR). Provide reports to program faculty from EHR regarding note timeliness, documentation completion and other metrics as determined necessary by Project Director. Handle all client and agency information with the highest degree of confidentiality and discretion. Answer phones, respond to emails, and interface with others in a professional and courteous manner. Perform other related duties as assigned, demonstrating flexibility and a willingness to contribute to the team in a dynamic work environment. Attend workshops, meetings, and trainings as requested by supervisor. Performs other related duties as assigned. What you will do: Excellent organizational skills and attention to detail. Ability to foster teamwork and cohesiveness. 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. Proficient in Microsoft Office Suite or similar software. What We Bring: Medical, Dental, Vision. Paid vacation, sick time, & holidays. 401K, HSA, & Life insurance programs. Organization committed to community action. Community oriented workplace. $28.85 - $28.85 semi monthly

Amity Foundation, an internationally acclaimed teaching and therapeutic community is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as a TPA Quality Assurance Specialist with this groundbreaking opportunity not only will allow you to work with our prison programs 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 Summary The Quality Assurance (QA) Specialist for Third Party Administrator (TPA)-Care First, Community Investment (CFCI) in partnership with L.A. County's Justice Care and Opportunity Department (JCOD) is responsible for the compliance of this project, developing and supporting a network of community-based organizations and non-profits as subrecipient Service Providers for Care First, Community Investment Funds. This position audits service delivery fidelity to awarded Grantees, service delivery and quality, licensure, certification, physical facility conditions, staff qualifications, and staff-to-client ratios as specified in individual contracts. This position collaborates with the Project Director, Director of Operations and Grant Advocates to maintain compliance and quality assurance of contracts with CBPs and optimize the utilization of CFCI and non-CFCI funds and comply with funding requirements. Essential Duties Responsibilities include, but are not limited to: Monitor subcontracted Service Providers and activities to ensure compliance with administrative and fiscal regulations in accordance with contract provisions. Work with network of CBPs to establish ongoing quality assurance monitoring processes and reviews. Review Program monitoring tool (Site Visit tool) of subcontracted Service Providers, and supervision implementation of corrective action plans to ensure high quality services are provided under CFCI and non-CFCI funding. Provide report updates to leadership team on matters relating to contract compliance. Maintain and update policies and procedures for the general operation of compliance programs. Respond to alleged violations of rules, regulations, policies, and standards of conduct by initiating investigative procedures. Reports on a regular basis, and as directed or requested to keep the TPA Project Manager and Director of Operations informed on the operation and progress of compliance efforts. Effective working knowledge of spreadsheets such as Excel, presentation software such as PowerPoint and word processing tools such as Word. Strong verbal presentation skills. Excellent interpersonal, written communications and typing skills. Demonstrated ability to work co-operatively with a multi-disciplinary team. Ability to analyze and organize data and prepare recommendations and courses of action. Additional duties as assigned. Education & Experience Required: Four (4) year degree in Social Sciences or related fields AND two (2) years of full-time administrative or quality experience working in a substance abuse program with criminal justice offenders OR Experience may be substituted for education on a year for year basis or possess Five (5) cumulative years of full-time administrative and quality control experience with a criminal justice population. Certifications & Licenses Required: NONE. Driver's License Skills & Abilities Excellent interpersonal and communications skills and the ability to work effectively with a wide range of constituencies in the community and within the organization. Knowledge of contract requirements, objectives, milestones, and other deliverables. Knowledge of contracting process and associated local, state, federal and other regulations. Ability to multi-task, identify problems, provide recommendations to management team, and implement any applicable systems. Ability to work constructively with diverse people and with parties that may have divergent perspectives and interests. Ability to clearly express concepts and direction, both orally and in writing, and to prepare complex reports, policies, and procedures. Understand and appropriately apply Amity policies and procedures and adhere to agency-wide practices and regulations. Strong oral and written communication skills. Proficient with software such as Microsoft Office Suite (Word, Excel. Email, Internet, etc.). Strong organization and time management skills Professional & Ethical Responsibility Ensure that excellence and integrity are applied to professional responsibilities in order to ensure optimal services are provided under TPA project; Understand and appropriately apply Amity policies and procedures, and adhere to agency-wide practices and regulations; and Model professionalism, effective work habits and responsible living Training & Continuing Education Within 90 days of hire, personnel file shall document evidence of participation in the following trainings (as relevant to TPA contract): Employee Orientation CPR Certification, First Aid Certification and an annual Tuberculosis (TB) test Sexual Harassment Prevention Emergency Procedures Confidentiality (Title 42 Code of Federal Regulations (CFR) Part 2) Health Insurance Portability Accountability Act (Title 45 CFR Part 164) Signed acknowledgement of Drug Free Workplace policy Participate in in-service training regarding the background and purpose of the TPA Project and all relevant policies and procedures. Participate in other training as assigned. $70,000 - $75,000 a year

Amity Foundation, an internationally acclaimed Teaching, and Therapeutic Community is seeking compassionate and enthusiastic individuals with a desire to teach, learn and join our community as an ECM- Quality Assurance Specialist. This groundbreaking opportunity will allow you to work with our prison and re-entry programs helping the community and 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 What You Will do: Regularly review ECM student files to ensure compliance with auditing standards set by local, state, and federal funding regulations. Collect, enter, and manage program data, ensuring accuracy and integrity of student records. Generate reports and submit data as required to support program evaluation and funding requirements. Regularly review services in the electronic health record system for possible errors, duplications, or other issues that could cause claim denials in an effort to make the reporting for month end billing seamless and to reduce the potential of claim denials. Prepare reports from the electronic health record system for the timely submission of claims, working closely with the accounting department to ensure proper reimbursement for services. Assist in the development and implementation of quality assurance policies and procedures. Maintain a thorough understanding of agency systems and policies to effectively support ECM program staff and contribute to quality improvement initiatives. Interface with contracted Managed Care Plan (MCP) electronic systems, including for client information sharing and service claiming. Manage receipt of student information files (MIF) from MCPs and provide MCPs with information regarding outreach and engagement status. Ensure complete client charts within agency's Electronic Health Record (EHR). Provide reports to program faculty from EHR regarding note timeliness, documentation completion and other metrics as determined necessary by Project Director. Handle all client and agency information with the highest degree of confidentiality and discretion. Answer phones, respond to emails, and interface with others in a professional and courteous manner. Perform other related duties as assigned, demonstrating flexibility and a willingness to contribute to the team in a dynamic work environment. Attend workshops, meetings, and trainings as requested by supervisor. Performs other related duties as assigned. What you will do: Excellent organizational skills and attention to detail. Ability to foster teamwork and cohesiveness. 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. Proficient in Microsoft Office Suite or similar software. What We Bring: Medical, Dental, Vision. Paid vacation, sick time, & holidays. 401K, HSA, & Life insurance programs. Organization committed to community action. Community oriented workplace. $28.85 - $28.85 semi monthly

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 Assurance Specialist. 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 Assurance Specialist will ensure that Amity Foundation complies with its external/internal regulatory and legal requirements as well as policies, procedures, and bylaws. The Quality Assurance Specialist 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.

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 Assurance Specialist. 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 Assurance Specialist will ensure that Amity Foundation complies with its external/internal regulatory and legal requirements as well as policies, procedures, and bylaws. The Quality Assurance Specialist 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

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. In the U.S, the salary range for this position is $ 31 to $ 50 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. The salary range for this position is: $31 to $50. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

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