Quality assurance specialist jobs in Conroe, TX - 280 jobs

Position: QA/QC Commissioning Associate III Location: Houston, TX Job Id: 796 # of Openings: 1 TITLE: QA/QC Commissioning Associate III LOCATION: Houston, TX POSITION SUMMMARY: The QA/QC Commissioning Associate III assists in quality control and quality assurance of data center critical systems preparing for the commissioning process. The QA/QC Commissioning Associate assists the QA/QC Engineer to ensure that the correct equipment has been purchased and that installation is in accordance with industry standards and equipment specifications. This role will develop skills and industry knowledge to perform increasingly more complex commissioning tasks. ESSENTIAL DUTIES AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform the following satisfactorily; other duties may be assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Develop QA/QC documents of the complete project including certificates, calibration, test results, inspection requests, non-compliance reports and site instruction/observations, permanent materials delivered, and other important QA/QC documents Follow all standards to perform inspection and tests on all procedures and oversee all testing methods and maintain high standards of quality for all processes Review the quality of all materials at the site and ensure compliance with all project specifications and quality and collaborate with the department for all material procurement and maintain a quality of materials Support the effective implementation of all test and inspection schedules and ensure adherence to all procedures and coordinate with various teams to perform quality audits on processes Assist employees to ensure knowledge of all quality standards and ensure compliance to all quality manuals and procedures and collaborate with contractors and suppliers to maintain the quality of all systems Manage to lift all types of equipment and handle the efficient storage of all hazardous materials and perform quality audits as per the required schedule Understand all products and non-conformance processes and evaluate all documents to ensure the maintenance of optimal quality and prepare monthly reports to evaluate performance Monitor an efficient system and record for all project activities and analyze all processes to ensure all work according to quality requirements Understand all work methods and maintain knowledge on all quality assurance standards and monitor continuous application for all quality assurance processes and recommend corrective actions for all processes Support and follow a method statement for the activity including risk assessment and job safety environmental analysis and Inspection Test Plan and Checklist based on specifications of the project Liaise the Technical Engineer for submission of material submittals to Consultant Develop and maintain inspection reports Ensure compliance to federal and state laws, as well as company standards and specifications Maintain calibration of quality testing equipment Perform inspections across all stages of production Advising on procedures to improve production efficiency Prepare and maintain test data for review Evaluate data and draft reports, noting any relevant deviations from existing standards Identify areas for quality control improvement and implement new methods accordingly Communicate quality or compliance concerns with urgency 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. Education/Experience (Desired): Technical Military MOS, trade school and/or degree Experience and/or education and internship in complex facilities or mission critical projects is preferred Any civilian or military technical certifications is a plus Experience with writing and enforcing standard operating procedures (SOPs) Solid understanding of test equipment & software Minimum of 5-9 years of inspection and/or production experience Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions Demonstrated ability to work independently with minimal supervision Excellent organizational skills Demonstrated ability to analyze and interpret information Must be a US citizen Must be able to travel 70% Computer Skills: Advanced Excel skills preferred Experience using Microsoft Office Suite, Word and Microsoft Project Basic knowledge of systems design for various projects Certificates and Licenses: No certificates or licenses required Supervisory Responsibilities: No supervisory responsibilities for this position. 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. Occasionally lift and or move objects 10 to 50; Frequently required to stand, walk, stoop, kneel, crouch or crawl. The employee is occasionally required to sit and climb or balance. Specific vision abilities for this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust and focus. Noise Level can be moderate to high. The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. CPG is an equal opportunity employer. We will consider all employment applicants without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. CPG Participates in E-Verify #:LI-TG1 Pay Range: $74,851 - $112,222 per year Apply for this Position

Work days/Shift Hours - if applicable: 4:00 PM - 4:00 AM / 2-2-3 Flex Schedule. Compensation: Starting pay ranges from $22.46 to $28.14 per hour, based on experience. Additional earning opportunities may include performance-based incentives, quarterly bonuses, referral bonuses, and comprehensive benefits. Additional Relevant Information: General Purpose Responsible for conducting qualitative and quantitative testing of raw materials and finished goods. Duties and Responsibilities Conduct qualitative and quantitative testing of beverages, syrups, and raw materials throughout the entire production process. Analyze syrup beverage and/or water attributes. Audit container rinsers, air blowers, filters, and coders to ensure proper operations. Conduct package quality inspection and quality audits and isolate product that does not meet standards. Receive and test CO2 and all raw materials prior to production process. Maintain highest possible housekeeping standards to prevent microbial contamination. Qualifications High School diploma or equivalent. Bachelor's degree in physical science and/or food industry experience preferred. 1-3 year of general work experience required. Prior food production operation experience preferred. Previous experience within high-speed industrial environment preferred. Ability to read and understand MSDS, operate manufacturing equipment, and knowledge of industrial technology a plus. Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain Texas or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Coca-Cola Southwest Beverages. Please inform us at if you need assistance completing this application or to otherwise participate in the application process. Know Your Rights dol.gov Coca-Cola Southwest Beverages LLC is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.

The Vendor Quality Assurance Manager is accountable for the service delivery and successful execution of all tasks across their quality assurance team. The Vendor Quality Assurance Manager will directly manage members of their quality assurance team and be responsible for guiding them through their career growth. They will be responsible for managing the work capacity all of their team members to adhere to communicated timelines and for monitoring the efficiency of the team through regular reporting on ticket throughput and defect rates. The Vendor Quality Assurance Manager will apply their depth and breadth of knowledge in facilitating team training and aligning team tasks to promote standards and scalability. They will also work with other departments to solicit feedback to search for and implement areas of improvement. The Vendor Quality Assurance Manager role requires a technical orientation, strong process/analytical skills to assist in the resolution of complex client issues, strong personal accountability, initiative, learning agility, Health and Welfare domain knowledge, and effective communication skills. ESSENTIAL DUTIES AND RESPONSIBILITIES Coaches others on the ability to translate vendor file requirements into test scenarios and test cases Collaborates with internal teams to understand current inefficiencies and works to implement improvements Maintains and coordinates quality assurance ticket tracking across the quality assurance team Analyzes test results and identifies issues and trends through metric reporting Leads efforts to promote quality assurance standards and team scalability Continuously learns, applies, and teaches new testing methods and technologies Demonstrates an in-depth knowledge of Health and Welfare processing knowledge, file requirements, and how those impact file data Leads effort to establish and maintain a vendor test plan library in support of all vendor relationships Helps to facilitate team training and cross organizational training on testing methodologies Supports execution of specialized projects as both SME and person accountable to ensuring completion of associated tickets Communicates regularly with external vendors to maintain positive relationships Promotes teamwork and strives to maintain high individual and team engagement scores REQUIRED SKILLS AND ABILITIES 7 + years of Benefit administration system and process experience 5+ years of experience creating and executing test plans 5+ years of using Microsoft Excel in a business environment 4 + years of SQL Experience 2+ years of demonstrated experience in coaching, mentorship, training and/or leadership role Understanding of data models/relational databases Ability to work independently and manage time in accordance with deliverables Excellent written and verbal communication skills Exhibits meticulous attention to detail Adaptable to new challenges and learns quickly in a dynamic environment KNOWLEDGE, EXPERIENCE AND/OR EDUCATION REQUIREMENTS Bachelor's degree preferred but not required In lieu of Bachelor's degree, 8 or more years of experience in business analytics, management information systems, human resources management, benefits administration or a related field 5+ years of file integration experience 8+ years of experience as a Business Analyst or Systems Analyst Knowledge of case or ticket management systems such as CRM or Atlassian JIRA Advanced understanding of testing methodologies and Health and Welfare business processes Any equivalent combination of education, experience, and training that provides the required knowledge, skills, and abilities will be considered Disclaimer: Managers have the right to assign or redesign the responsibilities of the above-mentioned job description without notice and at any time

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

Responsibilities 1. Interpret drawings and other sources of information. 2. Review product in various stages during the manufacturing process. 3. Inspect parts on both mill machines and lathe machines. 4. Perform gauge set up. 5. Perform dimensional inspection on material, product, and threads. 6. Verify first article including molding process. 7. Complete required documentation accurately. 8. Other duties as assigned by supervisor. Required Skills and Experience: 1. Knowledge of API & Premium connections. 2. Ability to read blueprints and instructions to comprehend quality specifications for the product. 3. Mathematical proficiency. 4. Knowledge of use of various types of inspection equipment including calipers, indicators, O.D. and I.D. micrometer, etc. 5. Strict attention to details. 6. Ability to pass eye examination.

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. Go anywhere Visit dsv.com and follow us on LinkedIn and Facebook. open/close Print Share on Twitter Share on LinkedIn Send by email

Introduction The Research Service Line at the Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) is seeking a Quality Assurance Specialist. This position is funded through the Houston VA Research & Education Foundation (HVAREF). This position is responsible for providing support to the Office of Quality Assurance for Research for studies conducted at the Michael E. DeBakey VA Medical Center (MEDVAMC) in support of VA research. Duties: Assists in updating policies and standard operating procedures. Assists in identifying and resolving process issues as well as making recommendations for continuous quality improvement. Assists with compliance and quality assurance issues and supports external regulatory site visits, providing regulatory input to minimize potential for non-compliance findings. Assists with organizing and compiling support documents and information for accreditation, audit, and site visit reports, submissions, and responses under leadership guidance. Serves on quality improvement/accreditation teams as requested. Collects and reviews Conflict of Interest Disclosures and training documentation. Assists in providing written or verbal instructions on deficiencies of protocol submissions and makes recommendations regarding modifications required to address deficiencies. Ensures accuracy of submitted materials. Works with investigators and staff, to resolve technical problems associated with research submissions. Provides customer service and education to Principal Investigators, Co-Investigators, and Coordinators for protocols submitted to the Research and Development Committee (R&DC), Subcommittee for Research Safety (SRS) and Institutional Review Board (IRB). Assists with initial review of quality improvement project determination. Assists with tracking IRB Continuing Reviews, amendments, 5-year projects, lapses, etc. Assists with regulatory oversight of various IRBs. Assists with Inputting and maintaining up-to-date Research databases (Informatics System for VA Research (ISVAR) and VA Innovation and Research Review System (VAIRRS) for research protocols. Performs other job-related duties as assigned. Requirements: The ideal candidate for this position has outstanding interpersonal skills. In addition to exceptional written and oral communication skills, the RQAS will be working with a variety of audiences to include research leadership, administrators, principal investigators, and research staff, and will need to be proactive in engaging relationships and building lines of communication to effectively generate and disseminate pertinent research communications. The candidate must also have no less than 3 years of clinical science research experience. Education: Bachelor's degree or greater in a Scientific Discipline, Business Administration, Health Care Administration or related field or four years of relevant work-related experience in health care or medical/academic setting can be substituted in lieu of a degree. Preferred: Master's degree in a related field. Experience in compliance, research, patient relations, health care, medical/academic setting or communications. Skills: Excellent oral and written communication skills. Excellent time management skills. Computer proficient. Strong attention to detail. Strong data collection and analysis skills. Supervision: Not required to supervise others. Customer Service: Takes routine or required customer actions to meet customers' needs Responds promptly and accurately to customers' complaints, inquiries, and requests for information and coordinates appropriate follow-up. Working Conditions: Work is performed in an office environment with pleasant working conditions. Eligible for a hybrid work arrangement following the successful completion of the probationary period. Physical Requirements: Rarely required to exert physical effort. Physical Risk: Does not handle/work with biohazards or risks for potential job-related injury. Benefits: Dental insurance Health insurance Life insurance Paid time off Vision insurance 401K Plan Schedule: 8-hour shift Monday to Friday **Position located in Houston, TX. Relocation expenses are not covered.**

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.

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 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

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: *********************************

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.

Job Description 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. Powered by JazzHR Ru6fpC3qgr

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

Responsible for the planning and coordination of contractual, operational and custodial services providing proper care, cleaning, maintenance and repair of buildings, grounds and facilities at multiple HCC campuses within a defined geographic region. ESSENTIAL FUNCTIONS Personally assess situations, obtain necessary information, draw conclusions and recommend and/or implement courses of action in accordance with normal practices and procedures; advise and/or train other professionals. Review job orders to determine work priorities, keep maintenance logs, and report on daily activities; help organize the activities and output of subordinate skilled trades' personnel or contracted vendors on a daily basis as a working supervisor or work leader. Coordinate and manage activities and performance of various contractual services ensuring compliance with EPA, OSHA, NFPA and TDLR policies on a federal, state and local level. Provide operational efficiencies through the practice of proficient resource management. Inspect and conduct proactive and reactive maintenance through subordinate skilled trades' personnel or contracted vendors of all facility services; including but not limited to, maintenance, engineering, landscaping, minor construction, plant maintenance, custodial services and parking activities. Provide leadership for quality activities associated with change management and expand quality system tools and procedures to support existing processes and report on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement to management. Conduct, document and present regular reports and reviews of quality control inspections and repairs. Develop and implement quality assurance/control standards and methods to measure/audit reliability and productivity of maintenance services work. Responsible for coordination of planning, organizing, coordinating, budgeting, reviewing, directing and controlling the maintenance of campus/location facilities through subordinate skilled trades' personnel or contracted vendors. Monitor, maintain and inventory equipment, tools and supplies, and order items as necessary. Perform other duties, tasks and assignments as required. QUALIFICATIONS Education & Experience * Associate's degree in Engineering, Architecture, Building Construction or related field required * High School Diploma/GED and 4 years relevant work experience in a construction trade may be considered in lieu of required degree * 5 years' related work experience in a facility maintenance or construction trade in a management role required Licensing & Certification * Valid Texas Driver License Special Skills * MS Office Programs * Budget Management * Project Management * Facility Management Software * Contract Management * General Maintenance Principles, Practices and Techniques Competencies * Delivering High Quality Work * Accepting Responsibility * Serving Customers * Supporting Organizational Goals * Driving Continuous Improvement * Acting with Integrity * Thinking Critically * Managing Change * Communicating Effectively Working Conditions General Office. Must be able to perform all job requirements with or without reasonable accommodations; remain in a stationary position during shift; move items weighing up to 25 pounds; position self to operate job equipment; apply established protocols in a timely manner. Must access, input and retrieve information from technology devices; communicate with others to accomplish job requirements. May be required to work after hours to include weekends and holidays. SECURITY SENSITIVE: This job class may contain positions that are security sensitive and thereby subject to the provisions of Texas Education Code § 51.215 The Organization Houston Community College (HCC) is composed of 14 Centers of Excellence and numerous satellite centers that serve the diverse communities in the Greater Houston area by preparing individuals to live and work in an increasingly international and technological society. HCC is one of the country's largest singularly-accredited, open-admission, community colleges offering associate degrees, certificates, workforce training, and lifelong learning opportunities. The Team Play a central role at HCC as you keep our everyday operations running like clockwork. You'll get the chance to make things happen and work closely with inspiring leaders across different parts of the institution. Whether your role is supportive, administrative, financial or something else, you'll be part of a dynamic team that not only provides HCC students with cutting-edge academic and career tools, it also takes care of its people. Location Houston is a city with limitless possibilities: * Fourth-largest city in the U.S. and home to 54 Fortune 500 companies, second only to New York City's 55. * Approximately 145 languages are spoken here. * Overall after-taxes living costs are 5.6 percent below the average for all 308 urban areas recently surveyed. * Houston is a major-league sports town, and don't forget the annual Houston Livestock Show & Rodeo. * The weather is great! Mild winters ensure that outdoor activities can be enjoyed year-round. * World-renowned medical care. The Houston metro area has long been known for its first-rate healthcare system, with many Houston area hospitals consistently ranking among the nation's top institutions. * With over 150 museums and cultural institutions in the Greater Houston area, museums are a large part of Houston's cultural scene. * Houston is the Culture & Culinary Capital of Texas with more than 7,500 restaurants and eating establishments covering 60+ cuisines. If this sounds like the role for you and you're ready to join an amazing team, please apply right away. EEO Statement Houston Community College does not discriminate on the bases of race, color, religion, sex, gender identity and expression, national origin, age, disability, sexual orientation or veteran's status. The following person has been designated to handle inquiries regarding the non-discrimination policies: Sandra B. Jacobson, J.D., M.Ed., SHRM-SCP, Interim Director of EEO and Compliance & Title IX Coordinator Office of Equal Opportunity and Title IX PO Box 667517 Houston TX, 77266 ************ or ******************* HCC values its employees and their contributions, promotes opportunities for their professional growth and development, and provides a positive working and learning environment that encourages involvement, innovation, and creativity. Individuals with disabilities, who require special accommodations to interview, should contact **************.

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

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

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.