Associate Director, Clinical Quality Assurance (Remote)
By MSD At , West Point $118,640 - $186,800 a year
Provide inspection management support as appropriate.
Design and actively participate in special assignments on various project teams and work streams as determined by QA management.
Provides training and mentorship to less experienced members of QA staff.
BS/BA degree in a relevant area with 8+ years of experience in the pharmaceutical industry.
GCP QA site audit experience.
Interfaces with relevant stakeholders, including regulatory, clinical and development sub-teams, as appropriate to provide Good Clinical Practice, Pharmacovigilance and QA expertise.
Quality Assurance Coordinator Jobs
By Prima Strategic Group At , Remote
High level of construction knowledge, skill and experience
Perform scheduled periodic Assessments of the Contractor's activities in order to evaluate and monitor implementation of Contractor’s quality management systems.
Evaluate Quality Metrics from Site, PQC and Engineering team and provide reports to responsible line management, PQM and Function, as required.
Advises and informs Sub-project Manager on Quality issues, status and metrics.
Review contractor’s standard contract and purchase order quality requirements language.
Worldwide experience with contractors, in particular those involved in the construction of offshore and onshore production facilities.
Assoc Gmp Quality Assurance Director - Clinical
By Exelixis, Inc. At , Alameda, 94502 $146,000 - $207,500 a year
Equivalent combination of education and experience.
Manages QA review of manufacturing records, clinical trial documentation and documents submitted to regulatory agencies.
Oversees and manages the GMP auditing process, and all other relevant QA inspectional activities.
BS/BA degree in related discipline and a minimum of 11 years of related QA experience; or,
MS/MA degree in related discipline and a minimum of 9 years of related QA experience; or,
PhD in related discipline and a minimum of 5 years of related QA experience; or
Quality Assurance Coordinator Jobs
By International Rescue Committee At , Baltimore
Bachelor’s degree required, preferably with a concentration in business administration, international affairs/policy management, non-profit management, finance and accounting, or related.
Good research, data management, and statistical analysis skills.
Provide analysis, evaluation and oversight to support compliance with grant requirements and organizational policies.
Review grant and contract agreements prior to execution to certify programmatic data collection methods will ensure compliance with contractual requirements.
Track and coordinate the satisfaction of compliance deadlines, requirements, and regulation implementation with deputy director and development team.
Excellent computer skills are required - especially Microsoft Office Suite.
Program Manager, Clinical Quality Assurance
By Takeda Pharmaceutical At , Boston, Ma
Solid judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines
Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Perform additional GCP related activities upon request by CQA management
Minimum of 5 years of experience in the pharmaceutical, biotechnology or related health care industry.
Minimum 2 years of GCP-related Quality Assurance or relevant clinical trial experience.
Quality Assurance Coordinator Jobs
By Fowler Packing At , Fresno, 93725, Ca
Proffer recommendations to company management on ways to improve on existing quality processes
Collaborate with an organization’s purchasing manager to ensure raw materials from external suppliers meet quality requirements
Prepare and present reports to update upper management on quality activities
Proven experience as quality manager
Excellent math abilities and working knowledge of data analysis/statistical methods
Conduct surveys to identify customer requirements and ensure they are being met by established quality standards
Quality Assurance Coordinator Jobs
By The Resource Exchange At , Colorado Springs, 80919, Co $86,837 - $90,455 a year
Skilled in Electronic Medical record management and other technology platforms within Office 365.
Plans, coordinates, and implements the quality management and quality improvement programs for a healthcare facility.
Knowledgeable and adheres to procedures related to physical, occupational and/or speech therapy services. Understands requirements of professional organization and payer services.
Knowledge of ICD-10 codes related to Physical, Occupational, and Speech Therapy services. Familiar with outpatient CPT codes and billing requirements.
Maintains a knowledge base of current HIPAA/regulatory/compliance issues.
Knowledgeable and proficient regarding Medicaid, Early Intervention, and other required documentation of physical, occupational and speech therapy services.
Quality Assurance Coordinator Jobs
By VNS Federal Services At , Denver, Co
Strong knowledge of quality management systems, standards, and regulations (e.g., ISO 9001).
Assist and/or conduct internal audits to assess compliance with quality management systems.
Bachelor's degree (BA/BS) in appropriate field of study, or equivalent combination of education and/or experience.
Strong organizational abilities, self-starter, and effective communication skills.
Manage the issuance and control of document numbers and transmittals.
Ensure compliance with applicable quality standards and regulatory requirements.
Quality Assurance (Qa) Coordinator - Construction
By Jacobs At , Los Angeles, 90002, Ca $68,000 - $78,000 a year
Knowledge in civil, structural, mechanical, piping, welding, Cross Country Pipeline experience, gas and fluid service, NDE and rotating equipment.
+2 years of experience in the natural gas/pipeline construction and/or inspection coordination
Effective communication skills (oral and written)
Knowledge in high pressure steel pipeline materials and components.
Typical salary range for this position is $68,000-$78,000 and is commensurate with experience relative to the position.
High level of attention to detail and organization
Quality Assurance Coordinator Jobs
By International Rescue Committee At , Silver Spring, Md
Bachelor’s degree required, preferably with a concentration in business administration, international affairs/policy management, non-profit management, finance and accounting, or related.
Good research, data management, and statistical analysis skills.
Track and coordinate the satisfaction of compliance deadlines, requirements, and regulation implementation with Deputy Director and Development Manager.
Provide analysis, evaluation and oversight to support compliance with grant requirements and organizational policies.
Review grant and contract agreements prior to execution to certify programmatic data collection methods will ensure compliance with contractual requirements.
Excellent computer skills are required - especially Microsoft Office Suite.
Quality Assurance Coordinator Jobs
By GC America Inc At , , Il
Demonstrated understanding of Quality Management System requirements (ISO, FDA, GMP, etc)
Drive the execution of daily management for related QMS processes, taking required action to investigate trouble reports and implement improvements.
Prepare and submit data and related evidence for QMS Management Reviews.
Provide Quality Management System training to operations and other departments, as needed.
Experienced in technical report writing and analytical skills
Ensure compliance with all established procedures and quality requirements, investigate and resolve discrepancies.
Clinical Quality Assurance Professional - Remote
By W. L. Gore & Associates At , Flagstaff, 86001, Az
Support the Clinical vendor qualification, selection, and management process
Working knowledge of inspection management
Demonstrated project management and leadership skills
Minimum of 3 years experience in the Biotech, Medical Device, Pharmaceutical or Healthcare industries
Minimum of 2 years experience in clinical and/or quality system compliance and auditing
Knowledge of Good Clinical Practices (GCP) and all applicable regulations
Director, Clinical Quality Assurance
By Arcus Biosciences At , Remote
Expert knowledge of global GCP requirements and applicable drug development regulations, including USA (FDA), EU (EMA, MHRA), and ICH Guidelines.
Experience leading audits of GCP vendors and investigator sites.
A strong team player with great interpersonal and written communication skills
Support clinical study teams for assigned studies through attendance at study meetings, review of study documents, and consultation on GCP-related questions.
Identify and escalate significant compliance issues to Clinical QA and other relevant leadership, including the assessment of serious breaches.
Maintain high level of expertise in global GCP regulations and internal policies and procedures that impact clinical study conduct.
Quality Assurance/Pi Coordinator
By Children's Healthcare of Atlanta At , Brookhaven, 30329, Ga

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Quality Assurance Project Coordinator
By Spectrum Staffing Services/HRStaffers Inc. At United States
Responsible for verifying that external QA consultants are qualified prior to assignment based on their education, experience and capabilities.
Generates metrics related to execution of the Unified Audit Program and the Vendor Management Program.
Proficiency with computerized systems used for audit and inspection management (e.g., Trackwise)
Manages QA eQMS (Trackwise) database entries for assigned auditors, planned and actual dates for audits.
4-6 years of Quality Assurance, biotech or Pharmaceutical experience required
Hands-on experience with MS Excel; PowerPoint; etc.
Clinical Quality Coordinator Assistant
By Ashridge At Harvey, IL, United States
Extensive knowledge of practice management and EMR technology.
Thorough knowledge of primary care practice and risk management.
Skill in establishing and maintaining effective working relationships with management, colleagues, subordinates, patients and the public.
Ensures on-going compliance with PCMH requirements to maintain PCMH certification.
Implement processes and programs with emphasis on quality management and patient centered care.
Knowledge and training on PCMH requirements.
Quality Assurance Coordinator Jobs
By MES Solutions At Norwood, MA, United States
Provides insight and direction to management on consultant quality, availability and compliance with all company policies and procedures and client specifications.
Ability to follow instructions and respond to upper managements’ directions accurately.
Participate in various educational and or training activities as required.
Must have strong knowledge of medical terminology, anatomy and physiology, medications and laboratory values.
Must be knowledgeable of multiple software programs, including but not limited to Microsoft Word, Outlook, Excel, and the Internet.
Must possess excellent skills in English usage, grammar, punctuation and style.
Quality Assurance - Clinical Research
By ViTalent At Westfield, IN, United States
Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
Education, Experience, Competencies And Skills
Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
Ensure compliance with Sponsor Learning Curricula, corporate and/or GXP requirements.
Regional Quality Assurance Coordinator
By American Addiction Centers At Hollywood, FL, United States
Experience in management within the substance use or behavioral healthcare industry.
Current knowledge of state and federal regulations and accreditation standards (CARF, TJC, etc.)
Minimum of two (2) years of work experience dealing with data sets, designing and developing data extractions, analysis, and reporting tools/dashboards.
Strong organizational and leadership skills.
Support assigned programs in achieving and maintaining Ongoing Survey Readiness.
Work closely with program staff to promote a culture of safety and quality.
Regional Quality Assurance Coordinator
By American Addiction Centers At Riverview, FL, United States
Experience in management within the substance use or behavioral healthcare industry.
Current knowledge of state and federal regulations and accreditation standards (CARF, TJC, etc.)
Minimum of two (2) years of work experience dealing with data sets, designing and developing data extractions, analysis, and reporting tools/dashboards.
Strong organizational and leadership skills.
Support assigned programs in achieving and maintaining Ongoing Survey Readiness.
Work closely with program staff to promote a culture of safety and quality.