Quality assurance specialist jobs in Webster, TX - 287 jobs

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

Quality Assurance Specialist About PROENERGY PROENERGY is a global and vertically integrated energy transition platform. Focused exclusively on fast-start, dispatchable power, our company supports both energy security and renewable growth with complete turbine services, project development, equipment manufacturing, turnkey generation facilities, operations, and maintenance. Our Footprint We are primed for the energy transition with permanent service locations in Missouri, Texas, and Argentina. Our world-class Missouri headquarters is purpose-built to meet dispatchable power needs. It sits on 90 acres in Sedalia and features more than 600,000 sq. ft of service capacity under roof, which includes the only independent Level-IV aeroderivative depot and string-test facility in the world. Our Houston, Texas, office is a strategic satellite positioned near our own dispatchable power installations. Our Philosophy We take care of our people and strive to make a positive difference for the world. We offer competitive pay, excellent benefits that include Medical, Dental, Vision, and Life/Disability Insurance at minimal cost to the employee, 10 paid holidays, paid time off, and a 401K plan. If you are looking for a rewarding career and possess specialized knowledge and quality-oriented problem-solving skills, we encourage you to apply today. The Quality Assurance (QA) Specialist is responsible for quality control oversight and process development related to the Gas Turbine Manufacturing (GTM) Department. Ensure that Gas Turbine Manufacturing is compliant with internal and external quality standards. Responsible for quality assurance of gas turbine components provided to the customer are met. Reports To: QA/QC Manager Work Location: 6401 North Eldridge Pkwy, Houston, TX 77041 Position Responsibilities Assist with all necessary requirements to meet or exceed ISO certification, as well as represent GTM as the ISO compliance specialist / liaison. Analyze quality data to promote continual improvement. Responsible for ensuring nonconformance & corrective action procedures are followed and documented. Procedure / process audits Assist on maintaining calibrated equipment Ensure inspection processes and documentation are carried out. Drive a culture of Quality on the shop floor. Assist with QMS maintenance. Participate in quality investigations. Train and instruct current and new employees. Required Qualifications High School Diploma or equivalent, some college preferred 3 years of experience in quality US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa. Successful candidate will need to satisfactorily complete pre-employment drug screen and background check. Desired Qualifications 2 years of supervisory experience Candidates must meet or exceed core competency expectations for safety, quality, productivity, attendance/punctuality, and teamwork. Candidates must have a mechanical aptitude and use strong working knowledge of common precision tools. Read and interpret drawings and specifications. Technical understanding of NDT methods and procedures used in the Power and Aero Industries. Ability to work under pressure in a fast-paced environment. Knowledge of Gas Turbine parts. Technical understanding of basic machining. Able analyze data and present trends. Technical understanding of software, hardware, networks, etc. Solid understanding of all NDT equipment used in repairing turbine parts and components. Additional Functions Knowledge of communication principles and practices. Foundational knowledge of the PROENERGY Quality Management System. Proficiency in use of calibrated tooling. Ability to function as Internal Auditor. Ability to analyze and resolve problems in a logical and effective manner. Ability to simultaneously manage multiple job assignments. Ability to communicate clearly and concisely, both orally and in writing. Exceptional attention to detail. Ability to follow directions and procedures. Adaptable to changing schedules. Team player, always looking for ways to improve. It is PROENERGY's policy to provide equal opportunity in employment to all its employees and applicants for employment without regard to race, color, religion, sex, pregnancy, age, disability, national origin, marital status, ancestry, medical condition, military status, or any other characteristic protected by State or Federal law.

Department: Quality Assurance Reports to: Associate Director, Quality Ops, Quality Assurance About CTMC CTMC is a pioneering biotech joint venture, formed by National Resilience and MD Anderson Cancer Center, located in the heart of the Texas Medical Center. Our mission is to accelerate cell therapies from bench to bedside. We offer a wide range of cell therapy modalities, including CAR-T, TIL, and TCR-T. Our expert team collaborates closely with MD Anderson's research and clinical faculty, bringing impactful cell therapies to cancer patients. Since inception in May 2022, our team has filed eight INDs and have received approval, without delay, demonstrating our commitment to delivering innovative treatments to patients with speed and precision. Our alliance with National Resilience enables us to remain at the forefront of biomanufacturing practices, leveraging advanced technology and processes to deliver exceptional results. Our growing, state-of-the-art, 60,000 sq. ft. industrial facility in the Texas Medical Center is staffed by an integrated team of industry veterans and academic scientists who are passionate about bringing life-saving cures to patients. Our unique joint venture structure, with two highly established partners, provides us with the financial stability and long-term horizon to achieve our organizational goals. At CTMC, we value our employees and offer a variety of development opportunities within our novel corporate structure to inspire professional growth and satisfaction. We foster a team-first culture and a balanced work-life environment to ensure our staff is energized and engaged in our mission to accelerate cell therapies from bench to bedside for patients who need them. If you share our passion for advancing the frontiers of medical science with innovative therapeutics and want to join a highly dedicated team committed to delivering novel cures to patients, we invite you to submit your application. We look forward to hearing from you and exploring how your skills and expertise can help us achieve our mission. Responsibilities: Review and approve QC test results, laboratory records, and batch analysis documentation. Investigate QC-related deviations, OOS/OOT results, and non-conformances. Participate in root-cause analysis and develop CAPA actions. Review, evaluate, and approve change control requests impacting QC processes or systems. Review and support method validation, method verification, and transfer documentation. Review equipment qualification records (IQ/OQ/PQ) and calibration documents. Conduct internal audits of QC laboratories and follow up on corrective actions. Assist with external audits by regulatory authorities and customers. Ensure data integrity and laboratory compliance with electronic systems (LIMS, ELN, etc.). Support disposition/ Hold/ Rejection of raw materials Partner with other departments to implement, optimize, review, and approve quality control records, practices, and procedures. Participate in audits when needed. Other duties as required. Qualifications/Skills Bachelor's degree in a scientific field required. 5+ yrs in Quality Assurance/Quality Control within the field or an equivalent combination of education and experience. Quality Control experience required Understanding of Cell and Gene Therapies. Understanding of cGMPs, GLPs and GXPs. Previous experience with LIMS systems (preferable LabVantage experience) Knowledge of local and global regulations. Verbal and written communication skills. Interpersonal and customer service skills. Organizational skills and attention to detail. Time management skills with a proven ability to meet deadlines. Analytical and problem-solving skills. Proficient with Microsoft Office Suite or related software. Working Conditions, Equipment, Physical Demands The incumbent in this position works in an office environment. The incumbent in this position will use the following equipment and shall have the following physical demands: Equipment- Computer, printer, fax, and telephone. Physical Demands- Prolonged periods of sitting at a desk and working on a computer and must be able to lift up to 15 pounds at times. In addition, ability to sterile-gown and perform activities in the manufacturing suite as well as raw material area when applicable. The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act. The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.

Company profile: Ingenia Polymers is a premier integrated solutions provider to the global polymers industry. For more than 35 years, Ingenia Polymers has developed a record of service, growth and reliability unsurpassed in the industry. Our talented people, culture of operational excellence, relentless drive to advance technology and breadth of capabilities make us the preferred supplier to our customers, with value added products and services supporting a variety of markets the world over. Ingenia Polymers is seeking highly capable and motivated people to contribute to our ongoing success and grow with us as we continue our international expansion. This is a great opportunity for individuals who want to take their career to the next level by joining a high-growth company with sophisticated production facilities, leading edge manufacturing technologies and innovative, progressive people. The job location is both in La Porte and Houston, TX. Learn more at ************************ Position Description and Requirements Summary: The QA Specialist is responsible for supporting manufacturing operations in 24/7 production lab and pilot plant. Require to operate laboratory instrument and equipment commonly used by the Plastics Industry. They will be expected to bring a high level of competency to the testing, analysis, and evaluation of Polyolefin Masterbatch and Compounding products filled with various additives. Essential Job Functions: • Develop analytical testing methods related to Polyolefin Masterbatch and Compounding products • Evaluate 24/7 analytical results, issue COA to meet specific customer requirements • Perform lab testing and tasks in accordance to lab Standard Operating Procedures • Maintain a safe and clean work environment and adhere to all safety, health and environmental guidelines • Provide full supports to operation 24/7 • Data compilation and reporting • Data analysis with basic SQC statistical methodology • Update and maintain lab standard operating procedures • Evaluate raw material COAs • Problem solving, investigating quality related issues to support internal and external customers • Some knowledge and experience in ISO 9001-2015, general quality management system, quality control • Some knowledge and experience in Lean Six Sigma, 5S, etc. Qualifications & Education: • Bachelor's degree in Science or related field • 2-7 years relevant laboratory experience; Plastics • Experience in Polyolefin Masterbatch and Compounding products • Experience in common fillers and various additives in plastics • Proficiency in Microsoft Office; Word, Excel, PowerPoint, and Outlook • Lean Six Sigma or statistical methodology • Certification for testing proficiency is a plus Competencies: • The candidate should have a general knowledge of lab safety with the ability to read and understand Material Safety Data Sheets (MSDS or SDS), Health Safety & Environmental (HSE), and Hazardous Materials Identification System (HMIS) labels • Must be able to work in a dynamic production lab environment, a team player who is dedicated to achieve the Company goals and objectives • Hands-on; detail oriented in testing, reporting and documentation • Must aid Time Management in all activities, and has to be able to handle multiple assignments, and deliver progress and results based on priority • Effective and accurate communication in a timely and accurate manner at all levels Physical Dimensions: • The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.

DSV - Global transport and logistics In 1976, ten independent hauliers joined forces and founded DSV in Denmark. Since then, DSV has evolved to become the world's 3rd largest supplier of global solutions within transport and logistics. Today, we add value to our customers' entire supply chain by transporting, storing, packaging, re-packaging, processing and clearing all types of goods. We work every day from our many offices in more than 80 countries to ensure a steady supply of goods to production lines, outlets, stores and consumers all over the world. Our reach is global yet our presence is local and close to our customers. Read more at *********** Location: USA - Houston, 831 Division: Air & Sea Job Posting Title: Quality Assurance Specialist Time Type: Full Time Summary As a Quality Assurance Specialist at DSV, you will be responsible for ensuring that all processes, procedures, and services meet the company's quality standards and regulatory requirements. Your role involves implementing quality management systems, conducting audits, and providing recommendations to improve operational efficiency and customer satisfaction. Duties and Responsibilities * Develop, implement, and maintain quality management systems (QMS) to ensure compliance with industry standards and regulatory requirements. * Establish quality control procedures and guidelines for various operational processes. * Conduct internal audits and inspections to assess compliance with quality standards, procedures, and regulations. * Identify areas for improvement and provide recommendations to address deficiencies. * Maintain accurate and up-to-date documentation related to quality management activities, including audit reports, corrective actions, and compliance records. * Ensure documentation meets regulatory requirements and is easily accessible for review and reference. * Analyze quality data and performance metrics to identify trends, root causes of issues, and opportunities for process improvement. * Collaborate with cross-functional teams to implement corrective and preventive actions to address quality-related issues. * Provide training and support to employees on quality management principles, procedures, and best practices. * Promote a culture of quality and continuous improvement throughout the organization. * Evaluate supplier performance and quality of products and services to ensure they meet DSV's standards and requirements. * Establish and maintain supplier quality agreements and performance metrics. * Monitor customer feedback and complaints related to quality issues and work with relevant teams to address customer concerns and improve satisfaction levels. * Implement customer-focused quality initiatives to enhance service quality and exceed customer expectations. * Stay informed about relevant industry regulations, standards, and best practices related to quality management and transportation logistics. * Ensure compliance with regulatory requirements and standards, such as ISO, FDA, and customs regulations. Educational background / Work experience * Minimum of 3-5 years of experience in quality assurance, preferably in the transportation and logistics industry. Skills & Competencies * Strong understanding of quality management systems and processes * Ability to conduct audits and inspections * Experience in developing and implementing corrective action plans * Analytical skills to identify trends and improve quality performance * Strong communication and interpersonal skills * Ability to work in a team environment * Strong organizational and time management skills Preferred Qualifications * Professional certification in quality management, such as Six Sigma or Lean Six Sigma * Bachelor's degree Preferred in Business Administration, Logistics, Supply Chain Management, or a related field. Language skills * Fluent in English (oral and written) Computer Literacy * Proficiency in Microsoft Office and experience with quality management software is preferred. At Will Employment DSV Air & Sea Inc. employees are hired for an undefined period of time as "at will" employees. This means that an employee may be terminated for any reason, or no reason at all, at any time, provided the discharge does not violate any law*. Additionally, each employee has the right to terminate his/her employment at any time. *Except if employed in Montana, where termination requires just cause. DSV is an equal employment opportunity employer. Candidates are considered for employment without regard to race, creed, color, national origin, age, sex, religion, ancestry, disability, veteran status, marital status, gender identity, sexual orientation, national origin, or any other characteristic protected by applicable federal, state or local law. If you require special assistance or accommodation while seeking employment with DSV, please contact Human Resources at *************. If you are interested in learning the status of your application, please note you will be contacted directly by the appropriate human resources contact person if you are selected for further consideration. DSV reserves the right to defer or close a vacancy at any time. For this position, the expected base pay is: $58,000 - $78,500 / Annual. Actual base compensation will be determined based on various factors including job-related knowledge, skills, experience, and other objective business considerations. DSV does not accept unsolicited agency resumes. Please do not forward unsolicited resumes to our website, employees, or Human Resources. DSV will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of DSV and will be processed accordingly without fees. DSV - Global transport and logistics Working at DSV means playing in a different league. As a global leader in transport and logistics, we have been on an extraordinary journey of growth. Let's grow together as we continue to innovate, digitalise and build on our achievements. With close to 160,000 colleagues in over 90 countries, we work every day to offer solid services and meet our customers' needs and help them achieve their goals. We know that the best way to achieve this is by bringing in new talent, fresh perspectives and ambitious individuals like you. At DSV, performance is in our DNA. We don't just work - we aim to shape the future of logistics. This ambition fuels a dynamic environment built on collaboration with world-class team players, accountability and action. We value inclusivity, embrace different cultures and respect the dignity and rights of every individual. If you want to make an impact, be trusted by customers and grow your career in a forward-thinking company - this is the place to be. Start here. 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Educator & Quality Assurance Specialist - CLC Sterile Processing - (2502955) Description REQUIRED EDUCATION / EXPERIENCE:High School Diploma or equivalent, Associate's degree in related field or 7 years'experience as supervisor with a background in Instrument Processing. Certified RegisteredCentral Service Technician (CRCST) and CHL Certification in Healthcare Leadership(IAHCSMM) are required. PREFERRED EDUCATION / EXPERIENCE:Five years recent leadership experience in the Sterile Processing or Operating Room,Certified Registered Central Service Technician Certification (CRCST) and CertifiedInstrument Specialist (CIS). JOB SUMMARY:The Educator and Quality Assurance Specialist for the Sterile Processing Departmentworks to promote the development of a motivated and cohesive team and supportseducational strategies to enhance staff knowledge with respect to processing practices andservice delivery. Supporting the Central Sterile Reprocessing operations and ensuringcompliance and standardization, the Educator/QA Specialist has responsibility to monitorand improve the processes used at the University of Texas Medical Branch SterileProcessing Department. This role will also have responsibility to audit High LevelDisinfection procedures within the department to ensure that all polices and best practicesregarding instrument reprocessing and sterilization are being followed. ESSENTIAL JOB FUNCTIONS:• Develops and implements a comprehensive orientation and education program for Sterile Processing staff.• Provides the technical expertise regarding standards and best practices in the fieldof sterile reprocessing especially as it relates to all appropriate regulatory agencieswho govern those standards.• Monitors all Sterile Processing Department quality systems and performs necessaryaudits for compliance practices, instrument sets in the Decontamination area,Assembly, Sterilization, Storage, and Case Cart preparation.• Audits the flow of instruments from SPD, through surgical procedures in the O.R.and back to SPD Decontam, making recommendations for improvement throughoutthe process.• Actively participates in service failure investigations, identifying root causes,developing and leading implementation of corrective actions, and conducting postimplementation reviews within the department.• Work with all departments and campuses to maintain proper documentation for thewashers and sterilization testing and operating processes.• Performs auditing of high level disinfection processes for all Sterile ProcessingDepartments at UTMB. Responsible for the systematic measurement, auditing andreporting of performance results and internal improvements in quality. • Collaborates with SPD front line staff and supervisors to resolve issues associatedwith processes within SPD (Included but not limited to work flow, equipmentrestrictions, etc.) • Coordinates education/in-service schedules for Sterile Processing staff.• Serves as an interdepartmental liaison to assess operational educational needs.• Participates in collaborative interdepartmental approaches to develop and enhancean integrated system of care, as appropriate.• Assists with the coordination of all joint operations for the program with both internaland external sources. Works with other campus departments to establishcollaborative programs.• Works with department managers, Infection Control and administration to establishquality standards and practices.• Maintains the quality assurance and performance standards programs for allcampuses.• Assists the departmental Manager in identifying and evaluating the need for newequipment, supplies, communication services, and information services for all areasof the program.• Utilizes Incident Reporting system for trending areas in need of improvement.Follows up on incident report communications• Conducts and incorporates an annual needs assessment for competency of staff. Qualifications Equal Employment Opportunity UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Primary Location: United States-Texas-WebsterWork Locations: 1667 - Clear Lake Hospital 200 Blossom Clear Lake Hospital,rm 3.107 Webster 77598-1667Job: Patient CareOrganization: UTMB Health: RegularShift: StandardEmployee Status: Non-ManagerJob Level: Day ShiftJob Posting: Jan 8, 2026, 7:09:02 PM

Adroit Advanced Technologies, Inc. Responsibilities: ● Responsible for monitoring and evaluating staff members on the quality and process of work performed as measured against standards. ● Assist with the development, analysis and distribution of recaps, findings and summaries. ● Assist with training new agents and re-training on policies and procedures. ● Remain proficient and up-to-date on policies and procedures for all operations. ● If needed, assist in developing new procedures, and update existing procedures when changes occur. ● Conduct agent monitoring activities, while providing live in the moment coaching for quality assurance purposes. ● Monitor and report on agent activity, schedule adherence, and productivity while reporting daily, weekly and monthly findings. ● Research, analyze, identify, and evaluate data from assigned tasks to evaluate existing and potential trends and issues while recapping for leadership. ● Perform other duties as may be assigned by leadership. Beacon Mobility is a growing family of companies committed to serving the diverse needs of our customers. Experienced, compassionate, and inspired, we take pride in our ability to create customized, mobility-based solutions that empower people to get where they need to go. Our purpose is simple - MOBILITY WITHOUT LIMITS: Transporting people to live, learn, and achieve. We are dedicated to providing those we serve with the opportunities, resources, and support to confidently move ahead. We support safe, compassionate, and inclusive environments that provide our communities with the mobility solutions they need to flourish and succeed. Backed by nearly 70 years of experience, Beacon Mobility operations can be found in Massachusetts, New York, Pennsylvania, Illinois and Minnesota providing support to over 10,000 employees in over 1,300 communities through the delivery of Paratransit and School Bus services leveraging a fleet of over 6,500 vehicles.

Reagent Chemical & Research, LLC. has been a leading US marketer of Hydrochloric Acid for over 65 years with terminals across the US, as well as truck and rail fleets. Employment with Reagent Chemical offers a competitive salary package, 401K with matching, profit sharing, 15 days PTO, 10 paid holidays, and a comprehensive health benefits package. Reagent is seeking to fill the position of Railcar Shop Quality Assurance Specialist at our AAR certified Tank Car Repair Shop located in the Channelview area of Houston, TX. This role will report directly to the Facility Manager. The Railcar Shop Quality Assurance Specialist is responsible for ensuring adherence to Reagent's Quality Assurance Program and work is performed in compliance with company, industry, and regulatory requirements which includes verifying that all repair and maintenance activities are conducted in strict compliance with company procedures, industry best practices, and all applicable regulatory requirements, including those set by the AAR and FRA. The specialist will play a key role in supporting audit readiness and promoting continuous improvement in quality and compliance across the facility. The position will be on 1st shift, working 8-12 hour days, and requires 40 hours with possible overtime. Principal Duties and Responsibilities Implement and oversee the Quality Assurance Program at the site level. Perform inbound, in-process and final inspections and audits of work performed on tank cars to ensure compliance with the quality assurance program, company procedures and regulatory requirements. Prepare work instructions for shop personnel. Oversee tank car inspections and repairs to ensure they are performed and documented correctly. Assist with tank car service equipment modifications to ensure they are performed and documented correctly. Review completed tank car inspection documents, photos and qualification dates stenciled on tank cars to ensure the requested work was performed and reported accurately. Compile and submit forms and documents to car owners and accounting. Perform incoming material inspections and place parts and material into designated areas. Maintain calibrated measuring and test equipment. Train employees on safety and quality procedures, forms and requirements. Oversee employee NDT certifications, safety training and other training and certification records. Monitor training and certification expiration dates to ensure there is no lapse and schedule or perform training and recertification as needed. Lead internal/external audits and prepare responses to audit findings. Initiate and complete nonconformance reports consisting of root cause, corrective action, and preventive action and process improvement plans. Lead and participates in continuous improvement opportunities. Assist with annual QA Manual review and updates and Management Review as required by AAAR MSRP M-1003 Section J. Ensure adherence to company safety policies, company procedures, and regulatory requirements. Performs other duties as required. Required Skills / Abilities Knowledge of the Association of American Railroads (AAR) AAR's Manual of Standards and Recommended Practices (MSRP) for tank cars specifications M-1002 and M-1003. Ability to navigate within the Federal Register and the AAR Circular Library to stay current with publication for rules, proposed rules, and notices from Federal agencies and organizations and the AAR. In-depth understanding of root cause analysis and corrective action plans. Proficient in computer software applications, including Word, Excel, Outlook, and other applications. Strong written and oral communication skills. Able to read and comprehend basic drawings and scopes of work. Strong attention for detail in identifying potential issues or safety hazards. Ability to operate effectively when faced with changing circumstances or uncertainty. Ability to clearly report findings and collaborate with team members to address them. AAR Basic and Lead Auditor Certification recommended. AAR Root Cause Analysis Certification recommended. Excellent communication skills (verbal and written). Must speak fluent English, bilingual in Spanish a plus. NDT Level II in BT, VT, PT, UTT a plus. Knowledge of rubber linings, rubber lining inspection, application, and repair experience a plus. Education and Experience: A minimum educational requirement is a high school diploma or equivalent. Minimum 5 years' experience in tank car repair quality assurance or tank car regulatory compliance. Previously held a tank car quality assurance position Hazardous Material (HAZMAT) training complying with Title 49 CFR Part 172 Subpart H in the last three years. Knowledge of regulations as they apply to Qualification and Maintenance of Tank Cars, specifically Title 49 CFR Part 180 Subpart F Physical Requirements: Must be able to lift 50 pounds at a time. Must be able to work in various elements indoors/outdoors. Must be able to pass a physical, drug screen, and background check Travel Requirements: Must be able to travel 1 - 15 days per year to attend training to enhance existing knowledge and skills. Placement agencies should not reach out regarding candidates. We will not reach out via text or make any offers before an in-person interview is completed. Please do not respond to any spam or fraudulent texts.

RESPONSIBILITIES: Documentation: * Writes, and approves Non Conformances, deviations, OOS's, &corrective action/preventative action (CAPA) management that impact plant operations and products and provide recommendations and corrective actions and effectiveness plans. * Performs problem analysis and CAPA management. * Acts as a technical resource within the plant for problem solving, training on the Non Conformances/CAPA system, and continuous improvement. * Compiles required Non Conformances and CAPA metrics. * Assembles Non Conformanceand CAPA information for monthly and quarterly management review presentations. * Monitors and analyzes plant Investigation and CAPA metrics and information. Ensures all deadlines are met for action items. * Completes customer complaint investigations as requested and per timelines provided. * Ensures that Non Conformances/CAPA documentation is compliant with site and Corporate policy/procedure requirements. Ensures investigations are approved by correct areas. * Assists manufacturing and other departments in identifying root cause and implementing effective corrective actions for those circumstances where quality standards are not met. * Trains new personnel on the Investigations and CAPA system. * Coordinates with QA Manager to determine if batch will be a designated validation or stability batch. * Maintains the effectiveness of the investigation system. * Other related duties as assigned. QUALIFICATIONS: * Bachelor's Degree, preferably in Science, Engineering, Math/statistics, or equivalent combination of education and experience. * 2+ years of non-conformance investigation experience. * 2+ years of experience in GLPor GMP environment. * 2+years experience reading, following, writing, reviewing, and approving SOP's, protocols, technical reports for validations (methods, processes, & cleaning), protocols for equipment validations, summaries of data, annual summary reports for water systems, environmental monitoring, etc. * Proficient in MS Office suite of programs (Excel, Office, Outlook, Power-point,etc). * Able to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, decimals and percentages; calculate figures and amounts such as proportions and percentages; apply concepts of basic algebra and geometry. * Able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. * Strong organization, attention to detail, and communication skills, both written and verbal. * Able to work with others in a positive team environment. * Able to follow instructions and provide guidance and instruction to others. At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer. We offer medical, dental, vision and company matching 401K. All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.

RadioMedix Inc., a Contract Manufacturing Biotechnology Company located at 19705 Aldine Westfield Rd. Humble, TX 77338, is seeking a Quality Assurance Associate (Operations) to work in radiopharmaceutical manufacturing. The successful candidate will play a key role in conducting Quality Assurance review of all drug products on-site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. The Quality Assurance Specialist I (Operations) role will be responsible for providing oversight over operations which includes validation and manufacturing operations. This role supports Quality Systems functions and operations. We're a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape. Roles/Deliverables Supports Quality on the Floor activities within a cGMP Operations in a 21 CFR 211 facility. Support the initiation and assignment of Quality Events such as (Deviations, CAPAs, Out of Specifications (OOS) Perform release of quarantined raw materials. Identify and assist in resolving issues related to the quarantine/rejection of materials. Completes documentation in accordance with GDP. Review executed records for GMP support areas to include facilities maintenance, materials management records and QC laboratory maintenance. Prepare and file all executed documents for archiving per standard operating procedures. Review training records and ensure training documents are filed and maintained files are up to date. Review equipment maintenance records and ensure equipment files are up to date. Assist in training staff in quality procedures. Prepare records for off-site record storage. Maintain and update tracking databases as required. Performs real time review of manufacturing batch records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. The Candidate Bachelor's Degree in a relevant life science field (e.g., Biology, Chemistry) preferred with 0-2 years of relevant Quality Assurance experience in pharmaceuticals, preferably working within an FDA regulated manufacturing facility. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint Demonstrated ability to work under aggressive timelines, demonstrated time management skills. Demonstrated excellent oral and written communication skills Demonstrated solid training and presentation/facilitation skills Demonstrated analytical, critical thinking and decision-making skills Demonstrated ability to work effectively and independently Demonstrated knowledge of procedures, documentation practices, GMP's and regulations associated with the manufacture of radiopharmaceuticals. Other duties as assigned. Residency Requirement: Employees must permanently reside and work in the State of Texas. Work Conditions The work environment consists of manufacturing, laboratory and office spaces. The position will sometimes require more than forty hours of work per week. The position is paid as hourly. The work period is typically between 8:30 AM to 5 PM. Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product or others at risk.

Job Description The QA Document Specialist will be responsible for maintaining proper documentation practices to ensure compliance to FDA, ISO, and other regulatory requirements as applicable, including drafting new documents and review of records. Duties and responsibilities Work with a cross-functional team to ensure all documents are properly stored and archived Facilitate the periodic review of documents to comply with internal QMS requirements Ensure completed documentation meets internal quality standards Draft documentation for batch records and raw material specifications Draft procedures for technical processes Data entry and basic statistical analysis Support the Internal Quality Audit program Inspection of raw material and in-process and finished products Assist manufacturing with batch release and other relevant documentation Assist with post-market monitoring of the company's products Assist with training and provide technical expertise as required Assist with supplier quality checks Assist with maintaining proper documentation of incoming and outgoing product Assist in other duties as assigned by the QA Manager Qualifications Have at least 2 years of relevant experience and a relevant bachelor's degree OR at least 5 years of relevant experience without a degree, preferably in the Medical Device industry Be able to work with a cross-functional team on an international stage Be able to communicate effectively in written and spoken English Be able to troubleshoot as necessary Be able to prioritize tasks effectively Show initiative and be proactive in their day-to-day tasks Preference for bilingual individuals that can speak and write Chinese, Spanish, French or German. Please note that this position is 100% in the office.

Join our Client's Team as a Document Preparation Specialist! Are you a detail-oriented person with a passion for precision? Do you thrive in a fast-paced environment where accuracy is key? If so, this position is for you! About the Company: Our client furnishes mortgage lenders with the peace of mind that comes from having provided timely, accurate, and compliant closing documents in more than 5 million residential loan transactions. That unprecedented volume of work results from our client's single-minded focus on serving residential mortgage lenders since the firm's founding nearly half a century ago. What We're Looking For: We're seeking a Document Preparation Specialist to join our client's talented team. As the backbone of their operations, you'll be responsible for ensuring the accurate and timely preparation of mortgage-related documents. From VA and FHA to Conventional and Texas-specific loan types, you'll be the go-to expert for all things documentation. Please note, this position is remote. What You'll Do: Dive deep into the world of Texas mortgage law as you review, prepare, and audit mortgage loan closing documents with precision and care Be the guiding light for our clients and team members alike, answering questions and providing expert guidance on loan documents and closing instructions for various lenders Utilize your expertise to navigate a variety of loan types, including VA, FHA, Conventional, Manufactured Housing, and more Stay ahead of the curve on industry regulations and compliance standards to ensure our documents meet the mark every time What You Bring: A sharp eye for detail and an unwavering commitment to precision. Experience in mortgage document preparation or a related field, with a comprehensive understanding of Texas mortgage laws. Proficiency in Microsoft O365 (Outlook, Word, and Excel) - you wield these tools like a wizard to ensure seamless document management and collaboration. Familiarity with multiple Loan Operating Systems, with a preference for IDS experience - you navigate these systems effortlessly to streamline our operations. Experience reviewing both title commitments and surveys - you see beyond the lines to ensure everything aligns perfectly. TRID and Construction experience is a plus - your versatility shines through with expertise in various regulatory requirements. Why You'll Love Working for our Client: A supportive team environment where your contributions are valued and your ideas are heard. Opportunities for growth and advancement in a thriving industry - we're invested in your success. A competitive benefits package including PTO, medical, dental and vision insurance, 401k and more - because we believe in taking care of our own. If you're ready to take your career to the next level and make a real impact in the mortgage law industry, we want to hear from you! Apply now and let's build something great together. Want to learn more about 512Financial? Check out our Recruitment and Talent Acquisition Page! If you have any questions, please reach out to us here: *********************************

Gray Hawk Land Solutions is currently hiring for the position of a Document Specialist to work in office in Houston, Texas. The individual we are looking for must have a complete understanding of all phases of a right-of-way project, be a self-starter, and able to perform the below tasks with little or no supervision. This position would be on site in the downtown area of Houston, Texas. Responsibilities & Qualifications: Must be highly organized and have good time management skills, must have a complete understanding of all phases of a pipeline right-of-way project from line list development to construction, and is expected to maintain accurate and current information on the overall status of the project Must have working knowledge and experience with all necessary right-of-way documents such as, but not limited to, land acquisition easements including courthouse recording requirements, temporary workspace documents, damages and compensation documents, excel spreadsheet tracking sheets etc. Maintain hard files, including easements, lease documents, real estate deeds, and various other documents relating to ownership and rights Create system line lists as requested Conduct in-house ROW and title searches as requested Scan documents into client system(s) of record Add specific metadata to documents in client system(s) of record Must have a proven history of reviewing and understanding land acquisition agreements Must be fluent in Microsoft Office software, including MS Excel and MS Word, and have an excellent understanding of database entry Must have the ability to learn new systems quickly Experience with geo AMPS or Pandell Projects and ESRI GIS software is preferred Understands general access reporting functions and the uses of formula/equation statements to optimize reports and reporting functions Must be able to multi-task and work efficiently during high-peak times Must be highly organized with the ability to prioritize work based on project timelines and ensure that timelines are not jeopardized Must have the ability to proof-read and have a keen eye for details to ensure the accuracy and completeness of reports and data Be proficient at typing and use a calculator, copier, postage machine, and other large and small equipment common to a project Excellent written and verbal communication skills Experience providing administrative support to a wide variety of users Represents self with professionalism. Can relate to people from various backgrounds and work well with others Able to work well in a team environment or an individual role Education/Experience: Minimum of Five (5) years of preparing and processing ROW acquisition easement documents on ROW projects. This position offers full health, vision & dental benefits.

Houston, TX Exp 3-5 yrs Deg Bach Relo Bonus Job Description Sign on Bonus available for candidates with at least one year current Clinical Documentation Specialist experience. Provide clinically based concurrent and retrospective review of inpatient medical records to evaluate the documentation and utilization of acute care services. Includes facilitation of appropriate physician documentation of care to accurately reflect patient severity of illness and risk of mortality. Will play a significant role in obtaining accurate and compliant reimbursement for acute care services and in reporting quality of care outcomes. Qualifications: Clinical Documentation Specialist experience required Minimum of 3 years clinical or inpatient coding experience in an acute care setting required; 5 years experience strongly preferred. Familiarity with coding concepts and coding software desired. Knowledge of care delivery documentation systems and related medical record documents. Knowledge of age-specific needs and the elements of disease processes and related procedures. Strong broad-based clinical knowledge and understanding of pathology/physiology of disease processes. Excellent written and verbal communication skills. Excellent critical thinking skills. Excellent interpersonal skills to build effective partnering relationships with physicians, nurse staff, hospital management staff, and health information systems coding staff. Ability to work independently in a time-sensitive environment. Computer literacy and familiarity with the operation of basic office equipment. Assertive personality traits to facilitate ongoing physician communication. Ability to stand and walk for periods of time is required in the performance of job responsibilities. • Working knowledge of Medicare reimbursement system and coding structures/national coding guidelines. • Graduate of an accredited school of nursing, AHIMA accredited school, international medical school Must possess a current RN or LPN license or an RHIA, RHIT, or CCS credential. Additional Information All your information will be kept confidential according to EEO guidelines. Direct Staffing Inc

Job DescriptionRadioMedix Inc., a Contract Manufacturing Biotechnology Company located at 19705 Aldine Westfield Rd. Humble, TX 77338, is seeking a Quality Assurance Associate (Operations) to work in radiopharmaceutical manufacturing. The successful candidate will play a key role in conducting Quality Assurance review of all drug products on-site. The focus of the position will be to focus on high-priority projects at RadioMedix that will be integral to upcoming clinical trials. The Quality Assurance Specialist I (Operations) role will be responsible for providing oversight over operations which includes validation and manufacturing operations. This role supports Quality Systems functions and operations. We're a growing company and we continue to add talent from a variety of fields. RadioMedix seeks to hire highly motivated and forward-thinking professionals interested in nuclear medicine research and development and influencing change within the Nuclear Medicine landscape. Roles/Deliverables Supports Quality on the Floor activities within a cGMP Operations in a 21 CFR 211 facility. Support the initiation and assignment of Quality Events such as (Deviations, CAPAs, Out of Specifications (OOS) Perform release of quarantined raw materials. Identify and assist in resolving issues related to the quarantine/rejection of materials. Completes documentation in accordance with GDP. Review executed records for GMP support areas to include facilities maintenance, materials management records and QC laboratory maintenance. Prepare and file all executed documents for archiving per standard operating procedures. Review training records and ensure training documents are filed and maintained files are up to date. Review equipment maintenance records and ensure equipment files are up to date. Assist in training staff in quality procedures. Prepare records for off-site record storage. Maintain and update tracking databases as required. Performs real time review of manufacturing batch records to ensure they are complete, accurate and compliant with current Good Manufacturing Practices (cGMP) requirements. The Candidate Bachelor's Degree in a relevant life science field (e.g., Biology, Chemistry) preferred with 0-2 years of relevant Quality Assurance experience in pharmaceuticals, preferably working within an FDA regulated manufacturing facility. Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to operate Microsoft Office software: Excel, Word, Outlook, and PowerPoint Demonstrated ability to work under aggressive timelines, demonstrated time management skills. Demonstrated excellent oral and written communication skills Demonstrated solid training and presentation/facilitation skills Demonstrated analytical, critical thinking and decision-making skills Demonstrated ability to work effectively and independently Demonstrated knowledge of procedures, documentation practices, GMP's and regulations associated with the manufacture of radiopharmaceuticals. Other duties as assigned. Residency Requirement: Employees must permanently reside and work in the State of Texas. Work Conditions The work environment consists of manufacturing, laboratory and office spaces. The position will sometimes require more than forty hours of work per week. The position is paid as hourly. The work period is typically between 8:30 AM to 5 PM. Individuals in this position will be exposed to ionizing radiation; however, radiation safety training will be provided, and radiation monitoring is required and ongoing at the facilities. Any exposure will be within Federal and State limits. Individuals in this position are required to be able to function and maneuver within the work environment without placing self, product or others at risk. Powered by JazzHR 3Xea6RCj2B

The Continuous Quality Assurance and Improvement Coordinator plays a key role in maintaining the high standards of care within our Residential Treatment Center. This position is responsible for overseeing the development, implementation, and evaluation of quality assurance and improvement initiatives. The goal is to ensure that the residential treatment services meet and exceed regulatory standards, accreditation requirements, and internal policies, while fostering a culture of continuous improvement. Key Responsibilities: Quality Assurance Monitoring: Monitor and evaluate the quality and effectiveness of care provided in the residential treatment center. Conduct regular audits, reviews, and assessments of treatment protocols, clinical records, and service delivery to ensure compliance with regulations, standards, and best practices. Identify areas of non-compliance or gaps in care, and develop corrective action plans. Data Collection & Analysis: Collect, track, and analyze data related to client outcomes, program effectiveness, and operational efficiency. Utilize data to identify trends, risks, and areas for improvement. Prepare and present reports to leadership teams, staff, and external stakeholders on quality metrics and progress toward improvement goals. Continuous Quality Improvement (CQI): Lead and coordinate CQI initiatives, promoting a culture of continuous learning and improvement across all departments. Collaborate with clinical, administrative, and support staff to design and implement improvement projects. Facilitate root cause analysis for adverse events, incidents, or other quality concerns, and ensure follow-up actions are taken. Training and Education: Provide training to staff on quality assurance processes, regulatory requirements, and best practices for improving client care. Support the onboarding of new staff in quality assurance protocols and the center's continuous improvement philosophy. Compliance & Accreditation: Ensure the center remains compliant with local, state, and federal regulations, as well as accreditation standards from bodies such as The Joint Commission or CARF. Support preparations for accreditation and licensing surveys, including documentation, policy reviews, and staff readiness. Client and Stakeholder Engagement: Gather feedback from clients, family members, and staff to assess satisfaction and identify opportunities for improvement. Coordinate client satisfaction surveys and conduct focus groups to gain insight into the effectiveness of treatment programs and overall service delivery. Policy Development & Review: Develop and review policies and procedures related to quality assurance and improvement. Ensure all staff are aware of and adhere to these policies. Qualifications: Bachelor's degree in healthcare administration, social work, psychology, nursing, or a related field (Master's preferred). Minimum of 2-3 years of experience in quality assurance, quality improvement, or program evaluation, preferably within a healthcare or residential treatment setting. Knowledge of accreditation standards (e.g., The Joint Commission, CARF) and regulatory requirements for residential treatment centers. Strong analytical skills with the ability to interpret data and generate reports. Excellent organizational, communication, and interpersonal skills. Ability to lead and collaborate in a team-oriented environment. Experience in using quality improvement tools (e.g., PDCA, root cause analysis, etc.) is a plus. Physical Requirements: Ability to sit or stand for long periods of time. Occasional lifting of up to 25 pounds. Working Conditions: Fast-paced environment requiring the ability to manage multiple projects simultaneously. Interaction with clients, staff, and outside agencies. Occasional evening or weekend work may be required for audits, training, or reporting deadlines. Job Type: Full-time Pay: From $30,000.00 per year Benefits: Paid time off Schedule: Monday to Friday Work Location: In person Compensation: $30,000.00 per year Our mission is to inspire youth to embrace the choose happiness, respond with love, and lead by example and Health (ENRICH) throughout their life journey. Our team is made up of highly trained and experienced professionals who are passionate about working with children. We cultivate a culture of continuous learning and improvement, and we are always looking for ways to enhance our services and better meet the needs of the families we serve. Saint Georgia, GRO (SG) services various types of neglect and abuse children with problems that require different treatment approaches. Saint Georgia, LLC GRO is a General Residential Operation that serves teenagers between the ages of 7 and 17 and who has been diagnose with some type of Emotional Disorder. We have developed a clinically program based on the specific needs of the residents, and our philosophy is based upon our beliefs and experiences related to the creation of genuine, lasting change in our residents.

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

The Quality Assurance Associate Manager / Quality Assurance Manager is responsible for overseeing and directing quality assurance activities for RadioMedix's Contract Manufacturing Facility, SPICA Center located 19705 Aldine Westfield Rd Humble, Texas 77338. This includes establishment of Quality processes for our internal manufacturing capabilities, oversight of external partners and management of ongoing manufacturing and lot release. Duties and responsibilities Duties and responsibilities Supports and/or lead onsite FDA Inspections and client audits Identifies and works with functional areas as appropriate to facilitate operational improvements. Reviews and approves product complaints and Annual Product Quality Reviews; tracks and trends product and line performance to drive quality improvements. Interacts and communicates with clients to assure expectations are established, agreed to, and achieved. Works to establish Quality Assurance processes/documents/systems for manufacturing operations. Builds impactful relationships and collaborations across the organization to achieve corporate goals. Performs Quality Assurance activities including, but are not necessarily limited to, review/approval of: Critical compliance documents in support of GMP Executed batch records for compliance Certificate of Analyses against raw data and/or specifications for compliance Stability report against protocol and raw data Release of RadioMedix owned raw materials, packaging components and products as needed Review of project-specific procedures, protocols, and reports as needed Support Quality Assurance Audits Support and/or lead RadioMedix Inspection Readiness Program, including mitigation plans Coaches and develops direct reports Works on continuous improvement projects, knowledge management, and strive for operational excellence Promotes and integrates quality into every aspect of our business Establishes quality on the floor to assist and support the manufacturing team in detecting and solving compliance errors in real time Quality review of regulatory filings in support of projects Other duties as assigned. Qualifications A bachelor's degree in a science discipline or related field is preferred Minimum of 6-10 years' experience in a quality assurance role of increasing responsibility, CQA a plus Higher level understanding of industry regulation 21CFR 211 Experience in Radioligand therapy preferred Experience in supporting Quality Control partnerships Advanced knowledge of manufacturing and analytical services in the pharma industry, radiotheranostic therapeutic knowledge preferred Working knowledge of GMP international regulations and ICH guidelines Strong problem-solving skills Ability to work independently and effectively as a team member with a multidisciplinary project Attention to detail with the ability to perform a critical review of various types of documents Strong organizational and time management skills

Job Description The Quality Assurance Associate Manager / Quality Assurance Manager is responsible for overseeing and directing quality assurance activities for RadioMedix's Contract Manufacturing Facility, SPICA Center located 19705 Aldine Westfield Rd Humble, Texas 77338. This includes establishment of Quality processes for our internal manufacturing capabilities, oversight of external partners and management of ongoing manufacturing and lot release. Duties and responsibilities Duties and responsibilities Supports and/or lead onsite FDA Inspections and client audits Identifies and works with functional areas as appropriate to facilitate operational improvements. Reviews and approves product complaints and Annual Product Quality Reviews; tracks and trends product and line performance to drive quality improvements. Interacts and communicates with clients to assure expectations are established, agreed to, and achieved. Works to establish Quality Assurance processes/documents/systems for manufacturing operations. Builds impactful relationships and collaborations across the organization to achieve corporate goals. Performs Quality Assurance activities including, but are not necessarily limited to, review/approval of: Critical compliance documents in support of GMP Executed batch records for compliance Certificate of Analyses against raw data and/or specifications for compliance Stability report against protocol and raw data Release of RadioMedix owned raw materials, packaging components and products as needed Review of project-specific procedures, protocols, and reports as needed Support Quality Assurance Audits Support and/or lead RadioMedix Inspection Readiness Program, including mitigation plans Coaches and develops direct reports Works on continuous improvement projects, knowledge management, and strive for operational excellence Promotes and integrates quality into every aspect of our business Establishes quality on the floor to assist and support the manufacturing team in detecting and solving compliance errors in real time Quality review of regulatory filings in support of projects Other duties as assigned. Qualifications A bachelor's degree in a science discipline or related field is preferred Minimum of 6-10 years' experience in a quality assurance role of increasing responsibility, CQA a plus Higher level understanding of industry regulation 21CFR 211 Experience in Radioligand therapy preferred Experience in supporting Quality Control partnerships Advanced knowledge of manufacturing and analytical services in the pharma industry, radiotheranostic therapeutic knowledge preferred Working knowledge of GMP international regulations and ICH guidelines Strong problem-solving skills Ability to work independently and effectively as a team member with a multidisciplinary project Attention to detail with the ability to perform a critical review of various types of documents Strong organizational and time management skills Powered by JazzHR 71EFn5lZfe