Senior Specialist Quality Assurance jobs at Abbott - 1920 jobs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: Quality Project Leader, Packaging Supplier Quality Working at Abbott Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac , PediaSure , Pedialyte , Ensure , and Glucerna - to help them get the nutrients they need to live their healthiest lives. At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will also have access to: Training and career development, with onboarding programs for new employees and tuition assistance. Financial security through competitive compensation, incentives, and retirement plans. Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1. Vacation - 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays. 401(k) retirement savings with a generous company match of 5%. Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The stability of a company with a record of strong financial performance and history of being actively involved in local communities. The Opportunity Our location in Columbus, OH, currently has an opportunity for a Quality Project Leader, Packaging Supplier Quality. Primary Function: The primary function of Supplier Quality Assurance (SQA) is to assure a high-quality supply of materials through evaluation and development of Abbott Nutrition suppliers worldwide. Packaging SQA is responsible for working and communicating with packaging suppliers as part of an ongoing supplier management process. Packaging SQA supports the following areas: (1) Supplier qualification, (2) Supplier development & monitoring, (3) Supplier corrective & preventative actions, (4) Continuous improvement of department & supplier performance, and (5) Regulatory documentation. Additionally, Packaging Supplier QA supports the plant quality assurance, operations, and purchasing groups to ensure (1) Proper incoming material, (2) Effective Corrective & Preventative Actions (CAPA), (3) Testing and release of products, and (4) Ensure acceptance plans and specifications are compliant to corporate and regulatory requirements. WHAT YOU'LL DO Collaborate closely with key packaging suppliers to monitor, assess, and enhance their quality performance. Assist with, initiate, investigate, and/or plan correction activities, as required, when nonconformances are identified and lead or support the resolution and closure. Support and influence suppliers to drive to true root cause and implement effective corrective actions. Evaluate supplier capabilities, identifying strengths and areas for improvement, and engage with supplier leadership to drive sustainable, long-term improvements. Own and manage supplier scorecards and KPIs; conduct weekly reviews to analyze performance trends and lead initiatives for continuous improvement. Lead investigations into quality issues using root cause analysis tools (e.g., 5-Why, Fishbone, statistical methods), ensuring effective corrective actions are identified, implemented, and validated. Conduct or support supplier site assessments, audits, and qualification activities to ensure systems, processes, and facilities meet Abbott and regulatory requirements. Manage supplier CAPAs and improvement plans, including exception report resolution and ongoing performance monitoring. Support the development of supplier systems and processes to improve quality, process capability, and compliance. Coordinate with Abbott manufacturing sites on supplier corrective actions, sampling plans, and validation of improvements. Ensure appropriate sampling plans are in place for routine production and post-corrective action verification. Maintain and evaluate the approved supplier list and ensure proposed process changes are reviewed and compliant. Required Qualifications Bachelor of Science degree in engineering, technical, or science field required. Preferred: Preferred experience within a Global, multi-cultural organization. Minimum of 3 years of experience in quality, packaging engineering, supplier quality assurance programs or related experience in operations, or quality assurance. Demonstrated ability to manage several activities / projects at once, organize / prioritize work. MISC: This is an onsite role located in Columbus, OH - this is not a remote role/opportunity. There is no relocation assistance for this role. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews. The base pay for this position is $68,000.00 - $136,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations QualityDIVISION:ANSC Nutrition Supply ChainLOCATION:United States > Columbus : 2900 Easton Square PlaceADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 15 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

A leading biopharmaceutical company is seeking a Senior Director of Quality Policy and Advocacy to lead global policy initiatives. This role requires extensive experience in Quality strategies, particularly within North American regulatory landscapes. You will be responsible for advocating Gilead's portfolio interests and engaging with stakeholders to resolve complex Quality issues. The ideal candidate will have a strong background in regulatory affairs, leadership skills, and the ability to communicate effectively with diverse audiences. This role offers a competitive salary and benefits. #J-18808-Ljbffr

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 purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. Review Clinical Study Plans that include device instructions. Requirements: BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. Medical Device experience required. Combination Product and Supplier Quality experience preferred. Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. Ability to consistently communicate with external parties in a professional manner. Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. Ability for occasional business Wisconsin pay range $130,000-$150,000 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

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 purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. Review Clinical Study Plans that include device instructions. Requirements: BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. Medical Device experience required. Combination Product and Supplier Quality experience preferred. Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. Ability to consistently communicate with external parties in a professional manner. Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. Ability for occasional business Wisconsin pay range $130,000-$150,000 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

This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities * Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses * Assist in generation, tracking, monitoring, and reporting of key quality metrics * Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams * Support health authority inspections * Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) * Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. * Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) * Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures * Work with Vendor Management Teams on identifying and mitigating any compliance issues * Oversee contract auditors and others perform audits on behalf of Arrowhead * Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories * Other duties consistent with the position as assigned from time to time Requirements: * Bachelor's degree in a science discipline is required. * 5 years of relevant experience in GxP auditing and compliance * Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines * Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience * Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial * Requires travel to other Arrowhead locations as well as domestic and international travel

The purpose of this position is to provide medical device quality assurance support at Arrowhead. This position will report to the Director, Supply Chain Quality and works closely with members of Quality, Operations, Supply Chain, Regulatory, and Commercial teams, as well as external stakeholders and suppliers. This position will provide Medical Device Subject Matter Expertise to support Quality and project teams to ensure clinical and commercial product quality are in compliance with relevant US and ROW medical device regulations, guidance, and laws. Responsibilities * Serve as an internal medical device subject matter expert, both US and ROW, for all relevant elements of QMS and quality of combination product development and commercialization, assuring proper integration and support of device regulations, including, but not limited to Change Management, Risk Management, DHF/DMR Maintenance, Internal Audits, etc. * Monitor, guide, and ensure internal stakeholders' decision-making and actions are consistent with QSR, ISO 13485, ISO 14189, Good Distribution Practices (GDP), relevant international laws and guidance, and Arrowhead policies and procedures. * Develop, define, support, review, augment, and/or approve a variety of controlled documents to ensure adherence to Medical Device Regulations and requirements. * Identify gaps in existing processes, as well as need for new processes. Collaborate with cross-functional teams for solution development and implementation. * Provide quality guidance to internal stakeholders and project teams during all phases of design control, risk management, human factor engineering, process development, verification/validation testing, packaging, and distribution, as well as lifecycle management of design changes and documentation. * Support continuous improvement to the combination product QMS, monitoring and identifying areas for improvement. * Support development and management of Supplier Quality activities such as Quality Agreements, supplier audits, and assessment and performance evaluations (SCARs, Customer Notifications, etc.) * Support internal audits, certifications, and regulatory inspections at Arrowhead and its suppliers. * Review Clinical Study Plans that include device instructions. Requirements: * BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred * Minimum of eight (8) years industry experience in Quality Assurance, in which at least five (5) of those years were in a leadership position with increasing levels of responsibility. * Medical Device experience required. Combination Product and Supplier Quality experience preferred. * Knowledge of GxP, focus on QMS, QSR, as well as ICH/FDA, EU MDR, ISO 13485 guidance documents and standards applicable to clinical and commercial products. Preferred: * Works independently, is organized, can multi-task and adjust priorities in a fast-paced, dynamic work environment. * Well-developed communication and interpersonal skills, with the ability to influence stakeholders at all levels. * Ability to consistently communicate with external parties in a professional manner. * Competent knowledge of and ability to use Microsoft Word, Excel, Adobe Acrobat, DocuSign, SharePoint and SmartSheet. * Ability for occasional business

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 This position will lead and participate in vendor audits on behalf of Arrowhead in accordance with GxP and/or other applicable regulations. This position will support the vendor qualification management team with management of the qualification records for Arrowhead vendors. This position may also assist with the management of quality events, review of procedural documents, and inspection readiness. Responsibilities Independently conduct Vendor Audits, Internal System Audits, and Clinical Trial Site audits, including issuing timely reports and facilitating finding responses Assist in generation, tracking, monitoring, and reporting of key quality metrics Facilitate ongoing quality improvement through communication of audit results, CAPAs and GxP guidance to the Quality and Business teams Support health authority inspections Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Critical Findings) Participate and lead in the lifecycle of Arrowhead Standard Operating Procedures and Work Instructions regarding GxP, industry guidelines, and global regulations. Assist in the issuance, review, tracking, and completion of Quality Events (e.g. deviations and CAPAs) Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures Work with Vendor Management Teams on identifying and mitigating any compliance issues Oversee contract auditors and others perform audits on behalf of Arrowhead Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories Other duties consistent with the position as assigned from time to time Requirements: Bachelor's degree in a science discipline is required. 5 years of relevant experience in GxP auditing and compliance Strong knowledge of GMP/GLP/GDP/GCP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines Prior GMP/GLP/GCP/GCP/GVP auditing, training, and/or compliance investigation experience Knowledgeable in Computer System Validation (CSV) and data integrity audits is beneficial Requires travel to other Arrowhead locations as well as domestic and international travel California pay range $105,000-$125,000 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

Manage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Cultivates and maintains Quality Assurance staff by recruiting, training, and managing QA team members. Align QA Analytical organization to meet company's strategic goals. Experience managing a QA organization in both clinical and commercial operations is beneficial Job Responsibilities: Leads and directs the QA Analytical team supporting analytical testing operations. Lead, assess, coach and develop departmental specialists. Manage performance, ensure team meets expectations and objectives. Guide the professional growth of team members by providing personal guidance and training relative to responsibilities Support GMP testing activities including release and stability testing. Oversees QA review of method qualifications, transfer, and validations. Oversees QA review of deviations, lab investigations, SOPs and GMP technical documents. Works directly with AFS and Microbiology to resolve deviations and other compliance issues in a timely manner. Communicates directly with clients to resolve issues related to GMP testing. Attend relevant operational meetings in support of issue resolution and escalation and batch disposition activities. Support client audits and regulatory inspections as required. Job Requirements: Knowledge, Skills, Abilities BS in scientific field with 8+ years' experience or MS and 6+ years' experience in a QA or GMP environment or equivalent. Experience in a in a QA role supporting GMP analytical testing is required. Minimum of 2 years of supervisory experience. Strong understanding of technical and compliance requirements for clinical and commercial biopharmaceutical programs and knowledge of US, EU and Row cGMP guidelines. Experience with electronic laboratory information management systems is preferred. Language Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Math Ability Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Physical Demands Support manufacturing and warehouse operations to include movement and/or lifting of raw materials and consumables. Computer Skills Knowledge of and experience using word processing, databases, spreadsheets, Power Point, Internet, E-mail, Calendar Management Equipment Knowledge of and experience using a computer, a telephone 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, 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.

Summary: This role is responsible for the implementation and management of Bureau Veritas Primary Integration's (BVPI) Quality Control Program at client sites; including the coordination, performance, and execution of construction inspections and testing services which lead to the successful delivery of commissioning and turn-over for clients in the Hyperscale Data Center Market. The QA/QC Manager will work with QA/QC professionals across MEP trade disciplines, General Contractor, and Owner QAQC Leadership to create and support a Quality Culture with tact, teamwork, and transformational leadership. Duties and Responsibilities include the following. Other duties may be assigned. • On-site Quality Assurance / Quality Control for assigned construction projects • Witnessing and reviewing site inspections • Ensure general contractor and MEP contractors comply with contractual and owner quality requirements • Familiarizes oneself with codes, local project regulations, construction practices, and the latest equipment and functional concepts • Coordinate quality issues between the design team, construction, and facility operations teams. • Provide personnel training to ensure awareness of quality procedures and specific responsibilities in the QA/QC process. • Help drive issues closure in client software and escalate any outstanding open items not getting closed out promptly. • Attend and actively participate in Construction Meetings • Produce detailed documentation using various clients software such as, but not limited to, BIM360, Compass, and CX Alloy. • Ensure that all inspection reports are accurate and that all attached documents are current. • Act with tact and professionalism to resolve conflicts. • Review inspection reports for compliance • Assist the site stakeholders in the administration and oversight of the quality control program • Prepare non-conformance reports and assist in developing corrective actions • Coordinate with the End User QC inspectors for the resolution of site problems **Required ***Ability to obtain upon hire • Coordinate with site subcontractors to deliver quality expectations • Assist the site subcontractors in the resolution of drawing interpretation • Attend the meetings as required • Review submittals, RFI logs, maintenance logs, and other project-related materials to confirm acceptability to quality and design • Assist in closeout documentation preparation as needed • Support the CM team in managing schedule and quality expectations • Keeps all relative parties informed via standardized communication protocol and tracking documents. • Additional duties may be assigned as needed at Management's direction • Train and coach junior associates to promote growth in the organization • Significant travel required for this role - 70% (rotating two weeks on project site and one weekend home) Qualifications: To perform this job successfully, an individual must perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Language Ability: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization. Ability to read, analyze, and interpret technical procedures and regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from managers, clients, customers, and the general public. Math Ability: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: To perform this job successfully, an individual should know Deltek and Microsoft Office 365. **Required ***Ability to obtain upon hire Education/Experience: Bachelor's degree (B.A./B.S.) from a four-year college or university; or equivalentcombination of education and experience. Certificates and Licenses: • Valid Driver's License** • CPR and/or basic First Aid*** • OSHA 30 *** • NFPA70E*** Equipment: Electrical and Mechanical testing equipment, as applicable Knowledge, Skills and Other Abilities: • Strong technical writing • Communication skills, both oral and written • Time management skills Physical Demands: The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands, climb or balance, stoop, kneel, crouch or crawl, talk or hear, and taste or smell. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 50 pounds. This job's specific vision abilities include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color. Work Environment: The work environment characteristics described here represent those an employee encounters while performing this job's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts, outdoor weather conditions, and risk of electrical shock. The employee is occasionally exposed to wet or humid conditions (non-weather), high, precarious places, extreme heat (non-weather), and vibration. The noise level in the work environment is usually loud. Work Schedule: This position may entail working more than 8 hours a day, and potentially working on Saturday or Sunday depending on project assignments

Summary: Responsible for providing engineering and technical support to plan, schedule, coordinate, and execute full life cycle commissioning of critical facilities, whilst under direct supervision. This position is also responsible for participating in the MEP design process, witnessing and/or performing the static and dynamic testing of mechanical, electrical, and controls systems, and for operating the system in normal, maintenance, and failure modes of operations by performing the following duties. Duties and Responsibilities include the following. Other duties may be assigned. 1. Assists in the development of commissioning plans.* 2. Assists in engineering design reviews.* 3. Interprets design and specification under direct supervision.* 4. Works in conjunction with senior engineers to fully understand scope and design as well as resolve issues, when necessary.* 5. Reviews shop drawings and submittals under direct supervision.* 6. Develops MEP test procedures under direct supervision.* 7. Develops MEP operating procedures under direct supervision.* 8. Provides input in the development of site specific load bank plans.* 9. Provides input in the development of commissioning schedules.* 10. Witnesses and/or performs the static and dynamic testing of MEP Systems, whilst under direct supervision, with examples that include chiller plants, air handling equipment, pumps, UPS systems, switchgear, and ATS switches.* 11. Conducts site observation surveys and prepares field reports on the status of projects and completion of projects with respect to compliance to the plans and specifications, whilst under direct supervision.* 12. Prepares daily reports, issue logs, and identifies corrective measures for on-site problems affecting commissioning, whilst under supervision.* 13. Familiarizes oneself with site specific requirements, as well as the latest equipment and functional concepts.* 14. Follows and obeys all project specific safety requirements, specific on-site *Essential Function **Required **Ability to obtain upon hire regulations, and company specific safety requirements and protocols.* 15. Performs routine calculations.* 16. Seeks to obtain and maintain accreditations pertinent to position.* 17. Assists the project manager in the reasonable execution of project tasks.* 18. Receives instruction from senior engineers and ensures proper execution of assigned tasks.* 19. Participates in professional trade associations and societies. 20. Performs various administrative duties. 21. Performs other duties as assigned. Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Language Ability: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Math Ability: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Computer Skills: To perform this job successfully, an individual should have knowledge of Deltek and Microsoft Office 365. Education/Experience: Pertinent and/or relevent industry experience; and/or one to two years related experience and/or training; or equivalent combination of education and experience. Certificates and Licenses: • Valid Driver's License** • CPR and/or basic First Aid*** • OSHA 10*** • NFPA70E*** *Essential Function **Required **Ability to obtain upon hire Equipment: Electrical and Mechanical testing equipment, as applicable Knowledge, Skills and Other Abilities: • Strong technical writing • Communication skills, both oral and written • Time management skills Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands, climb or balance, stoop, kneel, crouch or crawl, talk or hear, and taste or smell. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to work near moving mechanical parts, outdoor weather conditions, and risk of electrical shock. The employee is occasionally exposed to wet or humid conditions (non-weather), work in high, precarious places, extreme heat (non-weather), and vibration. The noise level in the work environment is usually loud. Work Schedule: This position may entail working more than 8 hours a day, and potentially working on Saturday or Sunday depending on project assignments.

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

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

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

The Role The purpose of this position is to ensure the successful quality and compliance management operations at all GTI sites. This position is to ensure through process performance audits that all raw ingredients, raw materials, packaging, and finished products comply with all applicable regulations and meet or exceed the customer's expectations and to act when predefined standards are not met. This position will also help manage product quality tracking systems, FDA standards, internal and external audits, etc. The goal for this role is to ensure compliance with all Green Thumb corporate operating procedures, as well as applicable federal, state, county, and municipal laws, regulations, ordinances, and regulations. Responsibilities Supports the Quality Department and ensure all employees understand and follow all standard operating procedures (SOPs). Define, implement, and improve the Quality Management System with guidance from the site Quality Manager including development of process and product testing to ensure quality standards are met and oversee determination of finished product disposition. Implement, maintain, and audit quality control practices and operations to ensure the safety, quality, and compliance of cannabis. Assist in site HACCP Plan and quality system reviews and provide recommendations for improvements. Assist the Quality Manager in the implementation of HACCP, allergen, sanitization, and other programs of the Quality Management System. Manage and perform document controller responsibilities through the Electronic Quality Management System. Oversee completeness and good documentation practices of in-process batch records. Partner with management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system. Perform or oversee routine audits of compliance processes to assure accuracy and thoroughness of completion. Participate in and facilitate state regulatory compliance inspections, investigate, and resolve compliance concerns, issues, or violations. Conducts weekly compliance risk assessments and identifies potential areas of vulnerability and risk, develops/implements corrective action plans for resolution of issues, and provides general guidance on how to avoid recurrence of same or similar issues in the future. Annual inventory planning and summary generation for regulatory (state regulatory body) submission. Label/packaging review and approval adhering to regulatory requirements. Works with Quality and Compliance Manager to identify all legal and regulatory requirements and legislative updates applicable to all the site's business lines and keeps up to date in changes of the regulatory requirements. Strong knowledge of compliance terminology, laws, rules, and regulations of industry and laws as issued by the state regulatory body. Provides guidance on various departments regarding compliance issues and implementation of new compliance requirements with respect to regulatory and contractual requirements. Conduct research on compliance topics, including but not limited to privacy, federal regulations, state laws and related publications for known risk areas. Ensures that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. Work with department leaders to troubleshoot any deficiencies that surface, to ensure issues get rectified quickly with high standard. Analyze facility trends to assess potential areas of continued non-compliance. Routinely reviews monthly corporate QA/QC documentation and assures that all areas of concern are addressed appropriately according to corporate policy and regulatory standards. Assist production personnel in the investigation of root causes and corrective action of internal rejects, corrective/preventive action, preventive control points, and customer complaints. Continually study the existing quality system and make recommendations for improvements. Perform assigned Quality Inspections. Perform improvement projects as identified. Collect quality data and report metrics to management. Monitors compliance to established Good Manufacturing Practice (GMP) guidance. Expected to adhere to safe work practices, follow GMP and HACCP guidelines, maintain sanitary conditions and ensure that product quality is maintained. Report to management any conditions or practices that may adversely affect product safety, product quality or personnel safety. Maintain a positive work atmosphere by acting and communicating in a manner so that you get along with customers, clients, co-workers and management. Perform assigned Quality Inspections. May make decisions and perform the job responsibilities of the Quality & Compliance Manager in their absence. Performs other duties as assigned. Working Conditions Work involves daily exposure to allergens (such as cannabis, tree nuts, and coconut oil). Qualifications Associate degree in Food Science, Biology, Chemistry, or a related field required, Bachelor's Degree in Food Science, Biology, Chemistry, or a related field preferred 3+ years of regulatory compliance management including interfacing with regulators and inspectors 5+ years work experience with a proven track record of building and developing QA/QC processes and systems Must have the knowledge and skills required to work in a fast paced and challenging environment Must be able to work variable day shifts dependent on business need Knowledge of the GMP, HACCP and Environmental sanitation programs Experience with SQF, ISO, GMP, ASQ, HACCP, PCQI or similar certification experience preferred QMS auditor or similar certification preferred Possess a strong knowledge of sanitary design, specification, and implementation of food\pharmaceutical processing systems Ability to deliver specific organizational goals and effectively develop, grow, and manage a diverse multisite team to achieve objectives Track record of engaging teams and creating a collaborative culture Excellent verbal, written and presentation skills Exceptional computer skills in Microsoft Office Suite (Access, Excel, Outlook, PowerPoint, Publisher, Word) Strong detail-oriented and resourceful mindset Additional Requirements Must pass all required background checks. Must be and remain compliant with all legal or company regulations for working in the cannabis industry. Must possess valid driver's license. Must be a minimum of 21 years of age. Must be approved by state badging agency to work in cannabis industry. The pay range is competitive and based on experience, qualifications, and/or location of the role. Positions may be eligible for a discretionary annual incentive program driven by organization and individual performance. Green Thumb Pay Range$65,000-$85,000 USD

is responsible for the compliance review of Biopharmaceutical Development GMP data. This includes the review and approval of release, in- is also responsible for the review and approval of method qualifications and validations. Another responsibility is the review and approval of laboratory investigations and deviations associated with the biopharmaceutical development department. JOB RESPONSIBILITIES: Performs compliance review on the following records: release, in-process, and stability data. Responsible for the review and approval of method qualifications and validations Responsible for the review and approval of deviations and laboratory investigations. MINIMUM REQUIREMENTS: BS and 11+ years experience or MS and 8+ years experience in a CGMP regulated environment within biopharmaceuticals or equivalent. Experience in QA review of analytical data (release, in-process, and stability), experience in reviewing method qualifications/validations and the review and approval of laboratory investigations and deviations. Knowledge of USP, EU and JP cGMP guidelines. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Basic math skills are required. Ability to apply concepts of basic algebra and statistics. Be able to sit for long periods of time. Ability to lift 20 pounds. Ability to use word processing, database, spreadsheets, power point, internet, e-mail, calendar, computer, telephone KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

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

We're looking for a Coding Quality Assurance Specialist III, someone who's ready to grow with our company. In this position you will assign and audit the accuracy of the ICD-10-CM and DRG Hospital Inpatient records for purposes of billing, research, and providing information to government and regulatory agencies. Ascertains the accuracy of the physicians' E/M and procedure coding to their documentation and completes the auditing reporting tool and provides this feedback to the education team and/or provider. Incumbent may perform only certain of the following Responsibility depending on their work assignment. Think you've got what it takes? Job Duties & Responsibilities • Assigns ICD-10-CM, ICD-10-PCS, and DRG codes to hospital inpatient records. • Reviews and interprets physician documentation to appropriately assign diagnosis and procedure codes. • Communicates with and provides feedback to the education team and/or providers. • Reviews patient charges to determine necessary coding to complete the account. • Identifies principle and secondary diagnoses and procedure codes from the electronic medical record. • Utilizes the encoder or coding books to generate ICD-10-CM, ICD-10-PCS, and DRG codes for diagnosis and procedures. • Sequences diagnosis and procedures to generate appropriate billing. • Utilizes other available resources for assignment of codes as necessary (e.g., Epic, MIQS, Cardio IMS, and coding reference materials). • Assists other coders in resolving coding problems. • Completes abstracts for records as appropriate. • Assists in correction of problem accounts. • Reviews charts for completeness. • Participates in education and maintains certification. • Assists in auditing records. • Maintains concurrent coding for inpatient records. Skills & Requirements • Required High School Diploma or equivalent • Requires one of the following Licenses/Certifications o CCA - Certified Coding Associate by the American Academy of Professional Coders (AAPC) o CCS - Cert-Cert Coding Specialist by the American Health Information Management Association (AHIMA) o CCS-P - Cert-CCS-P Physician Based by the American Health Information Management Association (AHIMA) o CIPC - Certified Inpatient Coder by the American Academy of Professional Coders (AAPC) o COC - Certified Outpatient Coder by the American Academy of Professional Coders (AAPC) o CPC - Cert-Cert Professional Coder by the by the American Academy of Professional Coders (AAPC) o CRC - Cert Risk Adjustment Coder by the American Academy of Professional Coders (AAPC) o RHIA - Cert-Reg Health Inform. Admins by the American Health Information Management Association (AHIMA) o RHIT - Cert-Reg Health Inform. TECH by the American Health Information Management Association (AHIMA) • Required 4 years coding experience with preferred experience using an encoder and experience using an electronic medical record Previous Hospital Inpatient coding of all specialties HIGHLY DESIRED

Quality Assurance Specialist Salary: $39,000 - $42,000 annually (Starting salary depends on education and experience) Job Type: Full Time ESSENTIAL RESPONSIBILITIES Compile, analyze, and share results and trends from monthly and quarterly reports for each program to report outputs and outcomes on performance measures and assist with internal programmatic benchmarking opportunities. Conduct monthly case reviews to oversee adherence to accreditation and licensing standards. Reports are developed to identify performance trends to better identify areas of opportunity to implement improvement strategies. Prepares monthly and quarterly performance reports for various programs Coordinates and conducts internal reviews of client case files for Agency programs and Prepares for contract audits and reviews with public and private agencies. Meet regularly with program leaders/operations to identify possible improvement opportunities. Review policies and procedures with programs to ensure meeting contract and accreditation standards. Participate in the development of new policies and procedures. Implement tools for periodic internal evaluations of compliance with standards. Oversees creation, implementation, and distribution of surveys for clients on various topics including customer satisfaction. Analyzes data and prepares reports of findings to program staff. Ensure adherence to the Performance and Quality Improvement plan through implementation, coordination, participation, and training of the organization's PQI system. Engage in the PQI process to help team members understand, embrace, and achieve key performance indicators Performs other related duties as assigned. QUALIFICATIONS: Bachelor's Degree required. The ideal candidate will also have at least two (2) to three (3) years of related experience. Must pass background check, physical and drug screening. This position also requires a valid driver's license and proof of current vehicle insurance. BENEFITS: Cornerstones of Care offers a competitive benefits package, which includes: Paid Holiday, Paid Time Away (unlimited PTO for all benefit eligible team members), medical/dental/vision; prescriptions; accident and critical illness insurance; pet insurance; short-term disability; long-term disability; term life and accidental death and dismemberment (AD&D); health savings account (HSA); flexible spending account (FSA); retirement (401K); employee assistance program (EAP); YMCA membership discounts; Tuition Reimbursement Program and Public Service Loan Forgiveness. To view a detailed Summary of Benefits please visit our website at ************************** and under the heading “About Us” click on “Join Our Team.” CORNERSTONES OF CARE'S ORGANIZATIONAL COMMITMENTS: Nonviolence-helping to build safety skills and a commitment to higher purpose Emotional Intelligence-helping to teach emotional management skills Social Learning-helping to build cognitive skills Open Communication-helping to overcome barriers to healthy communication, learn conflict management Democracy-helping to create civic skills of self-control, self-discipline, and administration of healthy authority Social Responsibility-helping to rebuild social connection skills, establish healthy attachment relationships Growth and Change-helping to work through loss and prepare for the future Questions? Please contact: Cornerstones of Care, Human Resources Department 8150 Wornall Road, Kansas City, MO 64114 Phone: ************** Fax: ************** Like us on Facebook at: ******************************************** Cornerstones of Care is an Equal Opportunity Employer

The Compliance/QA Specialist I performs various tasks that support the Compliance & Quality Assurance Department goals, objectives and functions to effectively prevent and detect violation of laws, regulations, policies or requirements. Supervisory Responsibilities: None Duties/Responsibilities: Perform routine and assigned audits, monitoring reviews and data collection using approved audit and monitoring instruments. Conduct demographic data entry (CalOMS Admission and Discharge) and/or corrections across behavioral health sites. Assist in the collection of charts and/or data for quarterly Drug Medi-Cal Utilization Review and other Utilization Review meetings and participates in meetings as assigned. Conduct behavioral health quality assurance chart audits. Perform behavioral health billing reconciliation tasks. Perform routine compliance activities, such as SBAT monitoring, exclusions screening, etc. in support of department goals. Maintain organized physical and electronic files and documentation of activities. Attend committee meetings, prepare meeting summaries as assigned. Other duties as may be assigned. Qualifications Required Skills/Abilities: Strong attention to detail. Reliability in attendance and assignments. Adherence to tight deadlines and ability to multi-task. Ability to critically think through problems and tasks, and conduct research to identify solutions and/or support decisions Ability to learn computer software programs (e.g. electronic health record systems, external portals, etc.) in order to perform job duties within 3 months of hire Strong display of agengy values: Compassion; Dedication; Integrity; Diversity. Basic knowledge of health care and social service systems. Knowledge of behavioral health documentation. Self-motivated; ability to work independently and with a team. Compliance with applicable federal, state, contract and agency regulations, policies and procedures regarding the privacy, confidentiality and release of patient and business information. Adherence to professional and ethical standards of conduct, and health and safety standards. Ability to display respect for cultural and lifestyle diversities of clients and staff. Education and Experience: Minimum 5 years' experience in behavioral health care field, preferably substance abuse. Bachelor's Degree in a health or human/social service or related field, or equivalent combination of education and experience. Experience and proficiency with MS Office Suite, especially WORD and Excel Physical Requirements: Following are the qualifications required to perform the essential functions of this position. Qualifications may be subject to modification based on the Americans with Disabilities Act. Vision, hearing, manual dexterity and eye-hand coordination must be adequate for performance of job duties. Able to sit at desk, use keyboard, write and physically perform other job duties. Prolonged periods of sitting at a desk and working on a computer. Able to move about the facility. The above statements reflect the general duties considered necessary to describe the principal functions of the job as identified and shall not be considered as a detailed description of all the work requirements which may be inherent in the position.