Quality Assurance Specialist jobs at Moderna

The ECMO Specialist is enrolled and actively participating in the department's ECMO Training Program. This role is responsible for developing and maintaining the skills necessary to proficiently and safely establish, manage, and control extracorporeal membrane oxygenation (ECMO) technology and assist with associated procedures in acutely ill patients of all ages in critical care settings. The specialist will learn to troubleshoot devices and associated equipment under the supervision of experienced ECMO personnel, provide ongoing care through surveillance of clinical and physiologic parameters, adjust ECLS devices as needed, administer and document blood products and medications in accordance with hospital standards, provide airway and ventilator management, and perform the full scope of practice of a Respiratory Therapist II. Schedule: 36 hours per week, rotating day/night shifts, every third weekend. **This position is eligible for full time benefits $20,000 sign-on bonus (not eligible for internal candidates and not eligible for former BCH employees who worked here in the past 2 years) Key Responsibilities: Assemble, prepare, and maintain extracorporeal circuits and associated equipment with assistance. Assist in priming extracorporeal circuits and preparing systems for clinical application. Assist with cannulation procedures. Assist in establishing extracorporeal support; monitor patient response, provide routine assessments, circuit evaluations, patient monitoring, and anticoagulation management. Assist with ECMO circuit interventions, weaning procedures, and transports. Administer blood products per hospital standards. Interact and communicate with caregivers, nursing, surgical and medical teams, patients, and family members. Maintain relevant clinical documentation in the patient's electronic health record. Participate in professional development, simulation, and continuing education. Attend ECMO Team meetings and M&M conferences on a regular basis. Minimum Qualifications Education: Required: Associate's Degree in Respiratory Therapy Preferred: Bachelor's Degree Experience: Required: A minimum of one year of experience as a BCH Respiratory Therapist with eligibility for promotion to RT II, or one year of external ECMO experience Preferred: None specified Licensure / Certifications: Required: Current Massachusetts license as a Respiratory Therapist Required: Current credential by the National Board of Respiratory Care as a Registered Respiratory Therapist (RRT); Neonatal Pediatric Specialist (NPS) credential must be obtained within 6 months of entry into the role Preferred: None specified The posted pay range is Boston Children's reasonable and good-faith expectation for this pay at the time of posting. Any base pay offer provided depends on skills, experience, education, certifications, and a variety of other job-related factors. Base pay is one part of a comprehensive benefits package that includes flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

Compensation Range: $65,000 - $70,000 yearly commensurate with experience Benefits: We have three comprehensive healthcare plans to choose from based on your priorities and budget. Housing Works covers most of the plan; you pay a portion, based on your salary. Staff begins accruing PTO immediately for a total of up to 30 days earned in the first year. We offer employees an educational benefit. This money is available for tuition loan reimbursement, tuition costs, and text books. Overview: The Quality Assurance Specialist (QAS) supports a comprehensive quality assurance program for Housing Works' Behavioral Health programming to ensure operating regulations for services are in compliance with state agencies, funders, and providing quality clinical care, primarily through comprehensive chart reviews. In this regard, the QAS ensures that programs, services, and facilities meet minimum acceptable standards, as defined in statutes and regulations, and that appropriate managerial oversight of programs and services exist to reasonably assure efficient and effective delivery of intended programs and services to the public. The QAS may also work as a liaison to state agencies Technical Assistance Support to attain and maintain established standards, as well as efficient and effective management practices. This is a 100% remote position. Candidates must have an active behavioral health license in NY State (LCSW, LMSW, LCAT, LMHC). Eligible to obtain up to 18 free Social Work CEs per year through internal training offerings Responsibilities: Primary: Complete monthly chart reviews of behavioral health programs; amount each month may vary based on program enrollment and program needs. Ensure regulatory adherence to pre-admission and admission procedures, criteria set forth for continued stay, and required discharge procedures. Review and audit admission assessments. Review and audit in accordance with clinical quality indicators, such as provided diagnosis basis in current DSM, assessment of level of care, and other appropriate care/admission indicators. Ensure appropriate protocol for outpatient care is documented in accordance with state agency and Housing Works' guidelines. Audit completion and timely submission of clinical documentation within client's chart to follow state and/or internal agency regulatory standards. Provide clinical assessment based on chart review on program practices/implementation of admission/treatment/discharge processes and training requirements. Provide technical assistance to behavioral health programs to support improvement of program performance with compliance, including conducting in-service trainings to behavioral health team members. Complete standardized review of behavioral health staff's compliance efficiency to utilize in assessing ongoing compliance of providers. Participate in agency and behavioral health departmental meetings that may be held on a weekly, bi-weekly, and/or monthly basis. This may include interdisciplinary and/or cross-departmental meetings. Identify challenges and shortcomings within clinical documentation that may influence corrective action steps geared towards improved adherence towards regulatory standards. Auditing data entry and generating reports as requested. Audit processes and report risk and/or billing issues in a timely manner. Secondary: Perform other duties and special projects as requested by supervisor. Participate in advocacy efforts and direct action to end the twin crises of homelessness and AIDS. Engage in monthly in-service training and other external trainings that are relevant to supporting or enhancing behavioral health program compliance. Minimum Requirements Master's Degree in the behavioral health from an accredited university (MSW, MA Psychology, MA in Mental health counseling, MA in art therapy) Must be a Licensed Qualified Health Professional (LCSW, LMSW, LCAT, LMHC) Experience with diagnosis/treatment in an OASAS and/or OMH licensed program. Demonstrated experience in collaborative projects involving multiple project partners, possessing strong written and verbal communication skills, organizational skills, and demonstrated experience with working as a member of a team. Ability to present information in a one-on-one and small group situation. Proficient in Microsoft Office programs, particularly Excel and Word. The equivalent of two (2) years' experience in planning and coordinating quality assurance initiatives [preferred]. Job candidates should be aware that scammers may pose as employers and create fake job postings in order to extract personal information from individuals for financial gain. Housing Works will never ask job candidates for personal information, such as social security numbers or bank account details, over the phone. If you suspect that a job posting may be fake or wish to confirm that a job posting from Housing Works is genuine, please contact us at **************************** Housing Works was founded in 1990; With a long-term commitment to AIDS advocacy. Housing Works established New York State's first harm reduction-based, OASAS-licensed outpatient drug treatment program. Other services include Health Home care management, behavioral health, and syringe exchange programs. A pioneer in the social entrepreneurship movement, Housing Works operates 10 high-end thrift shops in Manhattan and Brooklyn and a much-loved Bookstore Cafe in Soho. For more information, visit ******************** Housing Works fights for funding and legislation to ensure that all people living with HIV/AIDS have access to quality housing, healthcare, HIV prevention, and treatment, among other lifesaving services. Housing Works provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements. Housing Works complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. Housing Works also does not request prior salary information during the hiring process. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. This position is included in a bargaining unit of Housing Works' New York City employees represented by a labor union known as the Retail Wholesale and Department Store Union (“RWDSU”). Accordingly, the RWDSU has the exclusive right to bargain over the terms and conditions of employment related to this position and this position may become covered by the terms of a collective bargaining agreement (a “CBA”) between Housing Works and the RWDSU

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. We're offering a generous sign-on bonus ($20,000) to welcome you to our team. Recognizing and valuing exceptional talent, we're eager to discuss the exciting details of this bonus during our interview process. Flexible schedule (4x10 onsite or 5x8 with one remote day) This position is responsible for facilitating a comprehensive quality improvement program within the radiology department. Previous experience as a licensed imaging technologist is required for this position. Job Summary The Quality Assurance Specialist - MRI Research works as part of a multidisciplinary team following established policies and procedures and is responsible for safely operating and training research personnel to acquire research images on imaging equipment. * Participates in the day-to-day technical activities of a wide range of human and animal imaging research projects being conducted in the Radiology Research Imaging Core. Responsibilities include assistance in the implementation of radiology research imaging protocols in collaboration with Principal Investigators, Research Assistants, Clinical Managers, Physicists, Applications Specialists and QA Specialists. * Facilitates imaging protocol development on scanners in accordance with IRB and IACUC approved protocols and imaging manuals. Generates training documents to ensure accurate and consistent imaging acquisition and processing for longitudinal research results. * Daily operational tasks may include scheduling exams in Epic and Research Percipio, monitoring data transfer to Research PACS, assigning images to Principal Investigators and team, and obtaining safety reads by radiologists. * Working independently but under the general supervision of the Director, orders laboratory supplies, equipment, and services as needed. * All other duties, as assigned Qualifications Does this position require Patient Care? * Yes Essential Functions * Provide data consultation and staff support to clinical, operational process improvement individuals, patient safety individuals, etc. * Collect data, implement new protocols, provide education to staff in efforts to improve quality within the department * Collaborate with leadership, staff, and radiologists to ensure exam protocols, patient care processes, and image quality are optimized * Collects and analyzes quantitative and qualitative statistical data and work with vendors to resolve technical problems * Function as technologist to maintain optimal direct patient care skills and imaging skills * Provides radiation protection in accordance with prescribed safety standards; records digital images as directed for radiologist interpretation Education * Associate's Degree Health Science required Can this role accept experience in lieu of a degree? * No Licenses and Credentials * Basic Life Support [BLS Certification] - Various Issuers preferred * Heartsaver CPR AED [CPR] - American Heart Association (AHA) preferred * Magnetic Resonance Imaging [ARRT-MR] - American Registry of Radiologic Technologists (ARRT) required OR American Registry of Magnetic Resonance Imaging Technologists (ARMRIT) required Experience * Radiology Technologist experience with multiple patient populations 5-7 years required * Quality experience 2-3 years preferred Knowledge, Skills and Abilities * Good communication skills. * Ability to effectively evaluate and problem solve. * Ability to work independently. * Ability to guide, teach, and motivate others. * Good business acumen and analytical skills. Additional Job Details (if applicable) Physical Requirements * Standing Frequently (34-66%) * Walking Frequently (34-66%) * Sitting Occasionally (3-33%) * Lifting Frequently (34-66%) 35lbs+ (w/assisted device) * Carrying Frequently (34-66%) 20lbs - 35lbs * Pushing Occasionally (3-33%) * Pulling Occasionally (3-33%) * Climbing Rarely (Less than 2%) * Balancing Frequently (34-66%) * Stooping Occasionally (3-33%) * Kneeling Occasionally (3-33%) * Crouching Occasionally (3-33%) * Crawling Rarely (Less than 2%) * Reaching Frequently (34-66%) * Gross Manipulation (Handling) Frequently (34-66%) * Fine Manipulation (Fingering) Frequently (34-66%) * Feeling Constantly (67-100%) * Foot Use Rarely (Less than 2%) * Vision - Far Constantly (67-100%) * Vision - Near Constantly (67-100%) * Talking Constantly (67-100%) * Hearing Constantly (67-100%) Remote Type Onsite Work Location 221 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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.

Are you passionate about ensuring the highest standards of quality and compliance in the medical device industry? We are seeking a dedicated and dynamic Clinical QA Specialist to join our team onsite in Newark, DE! In this pivotal role, you will be responsible for the timely and thorough investigation and reporting of Potential Adverse Events, Adverse Events, and other regulatory reporting required due to complaints analysis. You will work closely with Technical Service, Marketing, Sales, Legal, and potentially Customers, fostering seamless communication and collaboration. This role requires your presence onsite, allowing you to make a tangible impact and drive excellence in our operations. Apply today! Knowledge: In-depth understanding of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, and ISO 14971 standards. Familiarity with medical procedures and expected outcomes related to the portfolio of products. Knowledge of complaint handling, post-market surveillance processes, and regulatory reporting requirements. Skills: Strong analytical and investigative skills to assess adverse events and identify next steps. Exceptional verbal and written communication skills to collaborate with internal teams, regulatory bodies, and external stakeholders. Proficiency in managing and innovating processes to improve compliance and efficiency in post-market surveillance. Ability to work independently while meeting deadlines in a fast-paced environment. Adept in handling metrics, indicators, and quality reports related to reportable events. Behaviors: High attention to detail and a commitment to accuracy in reporting and documentation. Proactive mindset with a focus on continuous improvement and innovation. Collaborative and team-oriented approach to problem-solving. Resilient and adaptable, thriving under pressure and regulatory scrutiny. Ethical and customer-focused, ensuring patient safety is the top priority. Experience: A minimum of 5 years' experience in a similar role involving post-market surveillance, adverse event reporting, and regulatory compliance. Hands-on experience working with cross-functional teams such as Technical Service, Marketing, Sales, and Legal. Track record of successful participation in internal and external audits, as well as regulatory agency interactions. Experience in executing investigations like CAPAs, NCEs, and IACAs to resolution. The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position. Why join Hologic? We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. The annualized base salary range for this role is $83,000 - $129,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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-NT1

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

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.

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

Job Description Responsibilities Job Title: Quality Assurance Specialist - US Reports to: Head of Quality & Regulatory FLSA Status: Exempt The Quality Assurance Principal is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Principal will be responsible for collaborating cross-functionally to support and guide product development. The Quality Assurance Principal will work cross-functionally and within the team to support the Quality processes, such as QMS training, complaint and CAPA management. Essential Duties and Responsibilities As the Quality Assurance Principal, this position will: Actively engage cross-functionally within the organization, such as with the Engineering, Clinical and Marketing teams, to develop new products within the Product Lifecycle Management (PLM) and New Product Introduction (NPI) processes. Act as the Quality lead for design changes to existing DeepHealth products, including non-medical devices, to ensure compliance with the applicable standards and guidances. Guide junior Quality Assurance team members to ensure consistent implementation of Quality processes, including design control and risk management. Take ownership of product specific Quality Management System processes, such as CAPAs and complaint management, across the organization to ensure compliance and drive efficiency. Work cross-functionally to integrate products as a result of corporate and/or product acquisitions. Work as a team member with the Quality Assurance team to ensure compliance to US and OUS standards and regulations. Participate in the development of junior staff, as requested Collect/monitor quality metrics in support of Management Review PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time. Minimum Qualifications, Education and Experience Bachelor's degree in relevant field (or equivalent experience, i.e. Associate's degree with 5 years of experience). Minimum of -10 working in a regulated industry (FDA and Software as a Medical Device preferred). Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62304 preferred. Knowledge and understanding of pre- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56, preferred but not required. Participation in regulatory audits a plus Excellent written and oral communication skills Physical Demands This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation. Working Environment Remote. This position requires domestic / international travel up to 15%. ACCOMMODATIONS Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

GEMCORE's continued success has earned us national recognition with Inc. Magazine's list of America's Fastest-Growing Companies and with the Cleveland Plain Dealer as a Top Workplace six years running! We are looking for qualified candidates who share our enthusiasm and drive for winning and want to be part of our caring culture! Are you looking to begin or further your career in the medical supply industry where you are able to contribute to the success of the business, and build lasting relationships? All while allowing for personal time every evening, weekend, and holiday? Edwards Health Care Services (EHCS), a division of GEMCORE , is a well-established and growing national direct-to home medical supply provider. We are seeking a highly motivated Diabetes Care Documentation Specialist to join our high energy team. The Documentation Specialist's primary role is to obtain documentation directly from physician offices for the purpose of qualifying a customer for prescribed supplies and maintaining compliance with Medicare, Medicaid, and commercial insurances. This is a full-time, non-exempt, entry level position. Once training is complete, this position will be part of a hybrid remote work schedule. The office is located in North Attleboro, MA. Schedule is 8:15am - 5:00pm, Monday through Friday. Employer paid vacation. Benefits available included medical/dental/vision, life, short and long-term disability insurances, and 401K Retirement Savings Plan. Ongoing training and development. Key Responsibilities Documents to include, but not limited to, medical documentation i.e. certificates of medical necessity, pharmacy prescriptions and lab work. Develop and maintain positive relationships with medical offices. Communicate with customer on issues relating to documentation and missing information. Data entry of updated customer account information for claim processing. Be knowledgeable of healthcare products, Medicare requirements, and various types of insurance coverage to determine customer eligibility. Outbound calls to physician offices to obtain all documentation and required forms. Faxing of forms or documents for completion by prescribing doctors. Job requirements Key requirements: Self-starter with the ability to work independently to achieve desired results. Clinical background helpful but not necessary. Efficient in Microsoft Outlook and Excel. Good organizational skills and multitasking ability Excellent telephone skills required. Word processing ability at minimum of 30 WPM. Good cognitive reasoning ability. Detailed and thorough work orientation. Minimum 1-2 years experience in a consumer service organization or healthcare environment. High School Diploma or GED Equivalent About Edwards Health Care Services, Inc. Edwards Health Care Services, Inc. (EHCS) is a national direct-to home medical supply provider of high quality medical and diabetes products that support the needs of individuals with diabetes and other conditions. For over 25 years, EHCS have been lighting the way to better health by providing customers an easier way to have products delivered directly to their door. By partnering with healthcare professionals, product manufacturers, and a large network of government and private insurers, EHCS prides itself on personalized customer service and a simplified, seamless order process for every customer…every time! For more information, visit *************** About GEMCORE GEMCORE, a family of companies headquartered in Hudson, Ohio - Edwards Health Care Services, GEMCO Medical, GemCare Wellness, and GEM Edwards Pharmacy - offers a core set of healthcare solutions by partnering with manufacturers, providers, employer groups, insurance groups, and patients to deliver high quality healthcare products and innovative services to proactively better lives. For more information, visit ********************** To learn more about this position and to view other openings, visit our career site: ************************************** All done! Your application has been successfully submitted! Other jobs

Site: The Brigham and Women's Hospital, Inc. Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. We're offering a generous sign-on bonus ($20,000) to welcome you to our team. Recognizing and valuing exceptional talent, we're eager to discuss the exciting details of this bonus during our interview process. Flexible schedule (4x10 onsite or 5x8 with one remote day) This position is responsible for facilitating a comprehensive quality improvement program within the radiology department. Previous experience as a licensed imaging technologist is required for this position. Job Summary The Quality Assurance Specialist - MRI Research works as part of a multidisciplinary team following established policies and procedures and is responsible for safely operating and training research personnel to acquire research images on imaging equipment. • Participates in the day-to-day technical activities of a wide range of human and animal imaging research projects being conducted in the Radiology Research Imaging Core. Responsibilities include assistance in the implementation of radiology research imaging protocols in collaboration with Principal Investigators, Research Assistants, Clinical Managers, Physicists, Applications Specialists and QA Specialists. • Facilitates imaging protocol development on scanners in accordance with IRB and IACUC approved protocols and imaging manuals. Generates training documents to ensure accurate and consistent imaging acquisition and processing for longitudinal research results. • Daily operational tasks may include scheduling exams in Epic and Research Percipio, monitoring data transfer to Research PACS, assigning images to Principal Investigators and team, and obtaining safety reads by radiologists. • Working independently but under the general supervision of the Director, orders laboratory supplies, equipment, and services as needed. • All other duties, as assigned Qualifications Does this position require Patient Care? Yes Essential Functions Provide data consultation and staff support to clinical, operational process improvement individuals, patient safety individuals, etc. Collect data, implement new protocols, provide education to staff in efforts to improve quality within the department Collaborate with leadership, staff, and radiologists to ensure exam protocols, patient care processes, and image quality are optimized Collects and analyzes quantitative and qualitative statistical data and work with vendors to resolve technical problems Function as technologist to maintain optimal direct patient care skills and imaging skills Provides radiation protection in accordance with prescribed safety standards; records digital images as directed for radiologist interpretation Education Associate's Degree Health Science required Can this role accept experience in lieu of a degree? No Licenses and Credentials Basic Life Support [BLS Certification] - Various Issuers preferred Heartsaver CPR AED [CPR] - American Heart Association (AHA) preferred Magnetic Resonance Imaging [ARRT-MR] - American Registry of Radiologic Technologists (ARRT) required OR American Registry of Magnetic Resonance Imaging Technologists (ARMRIT) required Experience Radiology Technologist experience with multiple patient populations 5-7 years required Quality experience 2-3 years preferred Knowledge, Skills and Abilities Good communication skills. Ability to effectively evaluate and problem solve. Ability to work independently. Ability to guide, teach, and motivate others. Good business acumen and analytical skills. Additional Job Details (if applicable) Physical Requirements Standing Frequently (34-66%) Walking Frequently (34-66%) Sitting Occasionally (3-33%) Lifting Frequently (34-66%) 35lbs+ (w/assisted device) Carrying Frequently (34-66%) 20lbs - 35lbs Pushing Occasionally (3-33%) Pulling Occasionally (3-33%) Climbing Rarely (Less than 2%) Balancing Frequently (34-66%) Stooping Occasionally (3-33%) Kneeling Occasionally (3-33%) Crouching Occasionally (3-33%) Crawling Rarely (Less than 2%) Reaching Frequently (34-66%) Gross Manipulation (Handling) Frequently (34-66%) Fine Manipulation (Fingering) Frequently (34-66%) Feeling Constantly (67-100%) Foot Use Rarely (Less than 2%) Vision - Far Constantly (67-100%) Vision - Near Constantly (67-100%) Talking Constantly (67-100%) Hearing Constantly (67-100%) Remote Type Onsite Work Location 221 Longwood Avenue Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $37.55 - $55.48/Hourly Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The Brigham and Women's Hospital, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington's disease, as well as a clinical program in obesity and a preclinical program in NASH/MASH. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Description As a member of Wave's Quality Assurance (QA) team, the Quality Assurance Specialist III, QA Training will be responsible for the oversight and maintenance of Wave's GxP Training program. This role partners with functional leaders to develop and maintain effective training that promotes employee competency and compliance readiness. This is an in-person role onsite at our Lexington facility requiring a minimum of 4 days onsite. Experience Bachelor's degree with a minimum of 4 years of related or transferable experience in the pharmaceutical or biotechnology industry, preferably in Quality Assurance/Training Experience in the administration of electronic learning management systems Veeva and/or ComplianceWire is preferred Experience in training program administration Experience working in a GMP manufacturing facility Responsibilities Manage the training program Creation and revision of role-based training curricula to align with functional responsibilities Manage onboarding of new employees by facilitating Quality onboarding training, verifying account creation and assigning curricula in Wave's Learning Management System Support the creation and revision of Training related SOPs, work instructions, training materials in collaboration with Subject Matter Experts (SMEs) Provide training and support for employees on the use of the Learning Management System (LMS) Support the development of training materials such as quizzes, instructor-led courses, and on-the-job training Facilitate GxP training for employees, as needed Oversight of training compliance across all departments, publish periodic training reports, and escalate compliance issues to management Collaborate cross-functionally to support LMS upgrades, vendor releases, and change management Manage or support the timely closure of relevant Quality System records Identify and participate in initiatives to improve the training program, LMS and training content Support development of Quality Management Review content to measure the health and effectiveness of the training program Support audits and regulatory authority inspections by providing training reports/documentation or other assigned tasks Oversight and timely response of training related inquiries Other duties as assigned Ensure timely completion of annual training review by providing support to functional leads and escalating issues to management Oversight of employees' CVs and job descriptions to ensure compliance Ensure timely generation and review of content for Annual GMP refresher training Key Skills Knowledge of GxP and Quality Systems principles with respect to US, EU, and other relevant regulatory guidance Superior organization skills with ability to manage competing priorities and meet deadlines Demonstrated ability to train GXP personnel one-on-one and in groups Works independently with minimal supervision Excellent team player with strong written and verbal communication skills Ability to work cross-functionally while providing excellent customer service Knowledge of instructional design principles for adult learning Champions continuous process improvement Proficient with MS Office Suite including Word, Excel and PowerPoint Pay Range External Disclosure Statement The annual base salary range for this position is $102,000 - $138,000 The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees' and their families physical and financial health and overall well-being. These include, but are not limited to, company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program. Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences' employees to perform their job duties may result in discipline up to and including discharge. We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.

Job Title- Specialist QA Duration - 12 months with possible extension Key Skills - QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs, Change Bio-pharma space / Biologics . M-F onsite • Knowledge in cGMP / GMP manufacturing and technical knowledge in validation of pharmaceutical processes/systems/equipment • Project Management and organizational skills, including ability to follow assignments through to completion Direct: ************ - Ext 2065 Qualifications • Bachelor degree in a science or engineering discipline • No less than 5 years of experience in the pharmaceutical environment and validation Additional Information All your information will be kept confidential according to EEO guidelines.

About this opportunity : The Quality Assurance Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a first shift position (Fri-Mon) and comes with a 10% shift differential. Key Responsibilities: Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists. Assist with production and QC to provide Good Manufacturing and Laboratory Practices. Understand and execute MQA responsibilities that are defined in SOP. Monitoring manufacturing operations including cleaning by conducting reviews of logbooks. Escalate detected major issues on the floor to MQA and QA management. Review facility cleaning, material transfers and personnel hygiene control. Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance). Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings identify, propose and lead continuous improvement projects. Provide Quality oversight and compliance guidance on new building program initiatives. Train, motivate, monitor, and lead quality teams through necessary change. Required Skills/Abilities: At least 3 years' experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred. Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations. Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight. Problem-solving skills with the ability to adapt to changing priorities and timelines. Ability to build positive working partnerships with other department teams. Experienced in the use of electronic systems such as eQMS. Prior experience with clinical and commercial manufacturing is preferred. Requires the ability to gown into clean rooms and wear PPE. The annualized salary range for this role is $67,900.00 - $83,100.00

Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will provide floor support to production departments to include line clearances, in-process checks and assistance with investigations. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team. Strategic Focus Area: Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge. Specific Responsibilities: Review and approve supplemental logs, charts and other documents in support of cGMP Operations. Review batch records for accuracy and completion prior to final release of product. Perform product releases specifically fills and intermediates lots. Coordinate product releases with distributors and customers as needed. Review and approve incoming materials for release. Provide quality assurance support of investigations including: nonconformance and root cause analysis. Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned. Issue, review and reconcile batch records as needed. Assist in the maintenance of the Quality System. Participate in project teams and perform other related duties as assigned. Job Complexity: Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance. Supervisor Responsibilities: none Required Qualifications: Bachelor's Degree or equivalent experience Medical device quality system management experience or an acceptable combination of education and experience will be considered. Internship experience may be considered. Knowledge of GMP, FDA, ISO requirements. Requires computer competence, including experience with database and Microsoft Office. Excellent written and verbal communication skills. Desired Experience, Knowledge, and Skills: Experience working in a GMP/ISO environment. Good presentation and organization skills. Attention to details. Capable of executing tasks per defined policies and procedures to resolve routine issues. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

About this opportunity : In this position you will support day-to-day QA Operations activities such as batch record review, release of raw materials, review of AA and HVAC reports, customer corrections and following cGMP practices and guidelines. This role serves as a key quality interface between operational teams and quality oversight functions. Key Responsibilities: Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements. Responsible for reviewing, approving, scanning, and binding quality records/batch records, and raw materials records. Responsible for knowledge of SAP system for release/rejection of raw materials. Maintains spreadsheets for the review cycles of quality documents. Interact /communicate with various department such as Manufacturing, Supply Chain and Quality Control. Coordinate corrections for quality documents internally and externally (e.g., client comments) Provide assistance during cGMP compliance inspections of the Milford facility. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections. Attend daily QA meetings. Support Senior/Lead Specialists. Gather/support corrections, quality metric reports to executive management. Provide strong link/communication between the QA function/activities with all other departments at the Milford site. Support Material Review Board (MRB) and labeling of raw materials (as required). Support Raw material re-evaluation process. Assist in customer documentation requests. Perform walk-through of manufacturing suites (as required). Help with internal audits of all GMP departments. Assist in deviation and investigation follow-up by coordinating data collection and document retrieval. Contribute to inspection readiness activities, document control harmonization, and trending initiatives in collaboration with QA Systems. Actively participate in continuous improvement efforts related to QA operations, document lifecycle management, and process ownership. Required Skills/Abilities: The job requires a BS/BA in science or equivalent work experience of at least 2 years' experience in either Production or Quality Assurance. Provide sound decision-making and guidance on all aspects of batch record review and raw material release. Provide strong link/communication between the QA Operations and QA Projects Departments. Interface with Manufacturing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities. Must be able to gown up and enter Manufacturing suites. The annualized salary for this position is $65,600.00 - $79,800.00.

Key Responsibilities - Support daily QA operations related to document control, change control, training, and CAPA management. - Review and approve production records, quality documentation, and deviations in compliance with internal procedures. - Assist with internal and external audits by preparing records, reports, and responses to findings. - Maintain and update Standard Operating Procedures (SOPs) and ensure proper document archiving and version control. - Coordinate and track employee training to ensure compliance with quality and regulatory requirements. - Support nonconformance and complaint investigations, assisting in root cause analysis and corrective actions. - Collaborate with QC, Production, and Regulatory teams to ensure cross- functional compliance and communication. - Monitor quality metrics and support continuous improvement initiatives within the Quality Management System. - Communicate effectively in both English and Korean across teams and departments. Qualifications - Bachelors degree in a scientific, engineering, or related field. - 05 years of experience in Quality Assurance or Quality Systems within a GMP or ISO 13485regulated environment. - Experience in medical device, pharmaceutical, or diagnostics industry preferred. - Bilingual in English and Korean preferred - Knowledge of ISO 13485, FDA QSR, and GMP regulations preferred. - Strong attention to detail and documentation accuracy. - Good understanding of quality processes and regulatory principles. - Ability to manage multiple priorities and meet deadlines. - Excellent interpersonal and written communication skills. - Proficiency in Microsoft Office Suite (Word, Excel, Outlook). - Team-oriented mindset with strong problem-solving skills.

Job Description Key Responsibilities - Support daily QA operations related to document control, change control, training, and CAPA management. - Review and approve production records, quality documentation, and deviations in compliance with internal procedures. - Assist with internal and external audits by preparing records, reports, and responses to findings. - Maintain and update Standard Operating Procedures (SOPs) and ensure proper document archiving and version control. - Coordinate and track employee training to ensure compliance with quality and regulatory requirements. - Support nonconformance and complaint investigations, assisting in root cause analysis and corrective actions. - Collaborate with QC, Production, and Regulatory teams to ensure cross- functional compliance and communication. - Monitor quality metrics and support continuous improvement initiatives within the Quality Management System. - Communicate effectively in both English and Korean across teams and departments. Qualifications - Bachelors degree in a scientific, engineering, or related field. - 05 years of experience in Quality Assurance or Quality Systems within a GMP or ISO 13485regulated environment. - Experience in medical device, pharmaceutical, or diagnostics industry preferred. - Bilingual in English and Korean preferred - Knowledge of ISO 13485, FDA QSR, and GMP regulations preferred. - Strong attention to detail and documentation accuracy. - Good understanding of quality processes and regulatory principles. - Ability to manage multiple priorities and meet deadlines. - Excellent interpersonal and written communication skills. - Proficiency in Microsoft Office Suite (Word, Excel, Outlook). - Team-oriented mindset with strong problem-solving skills.

Salary Range:$60,000.00 To $80,000.00 Annually Summary of Primary Responsibilities: The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, engineering ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records and approval of incoming materials for release. The position will provide floor support to production departments to include line clearances, in-process checks and assistance with investigations. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team. Strategic Focus Area: Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge. Specific Responsibilities: * Review and approve supplemental logs, charts and other documents in support of cGMP Operations. * Review batch records for accuracy and completion prior to final release of product. * Perform product releases specifically fills and intermediates lots. * Coordinate product releases with distributors and customers as needed. * Review and approve incoming materials for release. * Provide quality assurance support of investigations including: nonconformance and root cause analysis. * Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned. * Issue, review and reconcile batch records as needed. * Assist in the maintenance of the Quality System. * Participate in project teams and perform other related duties as assigned. Job Complexity: Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance. Supervisor Responsibilities: None Required Qualifications: * Bachelor's Degree or equivalent experience * Medical device quality system management experience or an acceptable combination of education and experience will be considered. Internship experience may be considered. * Knowledge of GMP, FDA, ISO requirements. * Requires computer competence, including experience with database and Microsoft Office. * Excellent written and verbal communication skills. Desired Experience, Knowledge, and Skills: * Experience working in a GMP/ISO environment. * Good presentation and organization skills. * Attention to details. * Capable of executing tasks per defined policies and procedures to resolve routine issues. The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law. submit your resume We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.