Laboratory Quality Specialist

We need to output HTML fragment only, with headings

for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. Must not include Job ID etc. Must preserve all substantive info, not invent or summarize away detail. Remove boilerplate, navigation, legal, EEO, etc. Also remove duplicated lines, application instructions. We need to parse the posting. Job Type Full-time (maybe schedule? but schedule not given). Description includes job title etc. We need sections: - About the role: likely from description paragraph about ASRT, assignment, scope of work. - Responsibilities: from "Major Duties And Responsibilities" list. - Requirements: from "Requirements" section includes Minimum Qualifications etc. - Qualifications: maybe separate? The posting has "MINIMUM QUALIFICATIONS" and "Desirable" etc. Could combine into Qualifications and Skills? But we need to follow instruction: Use headings only when posting has real specific content. We can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide which to include. We have content for About the role (description of ASRT, assignment, scope). We have Responsibilities (list). We have Requirements (minimum qualifications, etc). We have Qualifications (maybe same as Requirements? Could treat Requirements as qualifications). But we have also "Desirable" etc which could be Skills. Also "Language Skills" etc. We have no explicit Benefits, Pay, Schedule specifics. Pay says "SALARY: Commensurate with qualifications and experience." That is vague; we should not include Pay section because it's not specific (commensurate with qualifications and experience is placeholder). According to rule: never create Pay/Schedule/Benefits sections unless posting actually states them. "Commensurate with qualifications and experience" is not specific; it's like "commensurate with experience" which is prohibited. So we should omit Pay. Schedule: Not given; only job type full-time but no schedule details. So omit Schedule. Benefits: Not given. Omit. Thus we may have About the role, Responsibilities, Requirements, Qualifications, Skills. But we need to avoid duplication. Let's extract. About the role: The paragraph after "ASRT, Inc. provides scientific, information management, management consulting, bioinformatics, and administrative program support to the Centers for Disease Control and Prevention (CDC) and other Federal and private sector clients. The successful candidate will be a full-time employee of ASRT, Inc. and will be assigned to the Meningitis and Vaccine Preventable Diseases (MVPDB), National Center for Immunization and Respiratory Diseases (NCIRD), at the CDC, 1600 Clifton Road, Atlanta, GA, to support to the Bacterial Meningitis Laboratory (BML), Quality Management team and M&O team within MVPDB. SCOPE OF WORK The Laboratory Quality Specialist will provide scientific and laboratory support within the MVPDB, providing support services participate in the development, implementation, and maintenance of the Branch Quality Management System, as well as adherence to applicable guidelines and requirements" We can combine that into About the role. Responsibilities: list from "Major Duties And Responsibilities". Need to extract each duty as

. The text is a long sentence with many duties separated by periods? Let's parse: "Participate in the maintenance of the Branch Quality Management System and adherence to applicable guidelines and requirements established by Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO).Provide direct laboratory support for the implementation of quality system activities:Monitor equipment calibration and preventive maintenance activities.Coordinate equipment maintenance with vendors as applicable.Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards.Assist laboratories with documentation and investigation of nonconformances.Monitor competency assessments and proficiency testing.Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met.Assist branch quality team in performing periodic internal quality audits.Assist branch quality team in development and collation of data for branch quality management reviews.Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained.Analyze, review, revise, and/or interpret the data and prepare scientific reports, laboratory Standard Operating Procedures (SOPs), training materials, minutes, summary reports, abstracts, manuscripts, presentations, and other documents related to laboratory testing, training, specimen management, safety, and quality.Assist in placing orders, receiving, and ensuring that packing slips are maintained/uploaded, and all relevant trackers are updated.Manage in-processing of reagents and supplies, assist in QC and labeling, and with the supplies and reagents inventory.Assist/manage disposal of expired/hazardous waste." We need to split into separate items. Likely each sentence after a period is a duty. Let's list: 1. Participate in the maintenance of the Branch Quality Management System and adherence to applicable guidelines and requirements established by Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA) and the International Organization for Standardization (ISO). 2. Provide direct laboratory support for the implementation of quality system activities: - Monitor equipment calibration and preventive maintenance activities. - Coordinate equipment maintenance with vendors as applicable. - Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards. - Assist laboratories with documentation and investigation of nonconformances. - Monitor competency assessments and proficiency testing. - Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met. - Assist branch quality team in performing periodic internal quality audits. - Assist branch quality team in development and collation of data for branch quality management reviews. - Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained. - Analyze, review, revise, and/or interpret the data and prepare scientific reports, laboratory Standard Operating Procedures (SOPs), training materials, minutes, summary reports, abstracts, manuscripts, presentations, and other documents related to laboratory testing, training, specimen management, safety, and quality. - Assist in placing orders, receiving, and ensuring that packing slips are maintained/uploaded, and all relevant trackers are updated. - Manage in-processing of reagents and supplies, assist in QC and labeling, and with the supplies and reagents inventory. - Assist/manage disposal of expired/hazardous waste. But the instruction: Use

• for any list of duties/requirements/benefits. So we can make a flat list of duties; we could keep sub-items as separate
• as well. Probably best to list each distinct duty as a
• . We'll break them at each major verb. Let's extract duties: - Participate in the maintenance of the Branch Quality Management System and adherence to applicable guidelines and requirements established by CLIA, FDA, and ISO. - Provide direct laboratory support for the implementation of quality system activities. - Monitor equipment calibration and preventive maintenance activities. - Coordinate equipment maintenance with vendors as applicable. - Maintain records (training, equipment, monitoring records, NCEs etc.) in accordance with quality standards. - Assist laboratories with documentation and investigation of nonconformances. - Monitor competency assessments and proficiency testing. - Under the direction of the Branch Quality Team, work directly with laboratory staff to implement and ensure quality system requirements are met. - Assist branch quality team in performing periodic internal quality audits. - Assist branch quality team in development and collation of data for branch quality management reviews. - Work with branch quality team to ensure that all aspects of the branch QMS are developed, documented, implemented, and maintained. - Analyze, review, revise, and/or interpret the data and prepare scientific reports, laboratory SOPs, training materials, minutes, summary reports, abstracts, manuscripts, presentations, and other documents related to laboratory testing, training, specimen management, safety, and quality. - Assist in placing orders, receiving, and ensuring that packing slips are maintained/uploaded, and all relevant trackers are updated. - Manage in-processing of reagents and supplies, assist in QC and labeling, and with the supplies and reagents inventory. - Assist/manage disposal of expired/hazardous waste. That seems comprehensive. Now Requirements: The section "Requirements MINIMUM QUALIFICATIONS Education And Experience Bachelor’s or master’s degree in microbiology, biology, chemistry, or basic medical scienceMinimum of 4 years experience specializing in quality management within a regulated scientific environment. Required Experience adhering to applicable Quality Management Plan guidelines and requirements. (CLSI, ISO, CLIA, FDA)Ability to communicate effectively orally and in writingStrong CAPA, audit, and complaint systems experience is essentialStrong knowledge of established quality and reliability assurance practices, standards, and procedures, their content, and applications as applied to quality systems, manufacturing processes, and production methodologyStrong knowledge of Quality Control (QC) manuals, QC audit procedures, document package requirements, and overall Quality Assurance (QA) criteria specific to inspection reports, parts lists, revision levels, change orders, model numbers, classifications of defects, process test specifications, statistical sampling levels, acceptable quality levels, and others as applicableExperience using computer software packages including Microsoft Word, Excel, and PowerPoint Desirable Excellent oral and written communication skillsComfort working in a fast paced and highly interdisciplinary environmentExperience working with a diverse interdisciplinary team Language Skills The candidate must possess excellent oral and written communication skills in English. REQUIREMENT: Must be a United States citizen or permanent resident or have authorization for employment in the United States." We need to extract requirements as list items. Also we have "Desirable" etc which could be Skills. We need to separate Requirements (mandatory) vs Qualifications? The instruction says we can have sections Requirements, Qualifications, Skills. We need to decide what goes where. We have "MINIMUM QUALIFICATIONS" which includes education and experience. That could go under Qualifications. Then "Required Experience adhering to applicable Quality Management Plan guidelines and requirements." etc could be Requirements. Then "Desirable" etc could be Skills. Language Skills also could be Skills. Citizenship requirement maybe also Requirements. We must not invent or summarize away detail; we must preserve all substantive information. So we need to include all those points. Let's parse the Requirements block into distinct items. The block after "Requirements MINIMUM QUALIFICATIONS Education And Experience" is a run-on. Let's split by periods. Text: "Bachelor’s or master’s degree in microbiology, biology, chemistry, or basic medical scienceMinimum of 4 years experience specializing in quality management within a regulated scientific environment. Required Experience adhering to applicable Quality Management Plan guidelines and requirements. (CLSI, ISO, CLIA, FDA)Ability to communicate effectively orally and in writingStrong CAPA, audit, and complaint systems experience is essentialStrong knowledge of established quality and reliability assurance practices, standards, and procedures, their content, and applications as applied to quality systems, manufacturing processes, and production methodologyStrong knowledge of Quality Control (QC) manuals, QC audit procedures, document package requirements, and overall Quality Assurance (QA) criteria specific to inspection reports, parts lists, revision levels, change orders, model numbers, classifications of defects, process test specifications, statistical sampling levels, acceptable quality levels, and others as applicableExperience using computer software packages including Microsoft Word, Excel, and PowerPoint Desirable Excellent oral and written communication skillsComfort working in a fast paced and highly interdisciplinary environmentExperience working with a diverse interdisciplinary team Language Skills The candidate must possess excellent oral and written communication skills in English. REQUIREMENT: Must be a United States citizen or permanent resident or have authorization for employment in the United States." We need to add spaces where missing. But we can infer items. Let's list items: - Bachelor’s or master’s degree in microbiology, biology, chemistry, or basic medical science. - Minimum of 4 years experience specializing in quality management within a regulated scientific environment. - Required Experience adhering to applicable Quality Management Plan guidelines and requirements. (CLSI, ISO, CLIA, FDA