Qa Apheresis Auditor Jobs
By AstraZeneca At , Gaithersburg, 20878
Minimum 3 years’ experience in auditing and qualification of Apheresis/infusion centers for CGT products
Perform audit and site qualifications of Apheresis centers and infusion centers.
Perform qualification and audit of cell supplying vendors.
Knowledge of CGT products for clinical use in humans
Provide Quality oversight to Apheresis and infusion centers.
Liaison between Manufacturing site Quality and Apheresis/infusion centers on quality related issues.
Qa Auditor Ii Jobs
By Thermo Fisher Scientific At ,

Conductscomplex internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client ...

Sr. Gcp Qa Auditor - Remote
By Medpace, Inc. At , Raleigh, 27513
Develop audit management plans and audit strategy with clients for ongoing clinical trials.
5+ years of experience in a QA department in a related industry;
Experience conducting audits of vendors and investigative sites;
Experience hosting regulatory authorities and interacting with sponsor/client representatives;
Knowledge and application of Good Clinical Practice (GCP) is required;
Medical Device and or Phase 1 experience is a plus;
Associate Manager, Qa Gcp Auditor
By Regeneron At , Tarrytown
Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
Drafts and issues periodic reports to site management as requested
You have excellent interpersonal skills and ability to work with people in all levels of the organization and externally.
We seek candidates with proven skills in taking initiative and working independently
Good problem solving, written and verbal communication skills
Ability to effectively manage multiple priorities with a sense of urgency
Qa Gcp Auditor 2 Jobs
By IQVIA At , Remote
Evaluate audit findings and prepare and distribute responses to operations staff and management.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors.
Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications
Manage Quality Issues and serious breach investigations.
Qa Receiving Technician Jobs
By Reckitt At , Salt Lake City, 84101
General knowledge of cGMP for Dietary Supplements
General knowledge of Logistics Receiving, QA Receiving and QA Release procedures
Good communication skills, both verbal and written
High School education or equivalent required
Work experience in technical field preferred
Competitive Salary & excellent benefits package
Qa Auditor Jobs
By Clario At , Remote
Assist with the hosting and management of client audits.
Support Continuous Improvement program and conduct internal meetings to support management of issues
Knowledge of 21CFR Part 11, 21 CFR 820.20, ISO 9001/13485 and applicable regulatory authorities
Excellent leadership, analytical, organizational and communication skills
Analyze any observations identified and work with applicable departments to generate effective corrective and preventive action responses
Develop auditing plans and compile reports for assigned audits
Qa Auditor Jobs
By PCI Group Inc At , Irving, 75061, Tx
Other duties and responsibilities as directed by the QA Lead and/or Quality Assurance Manager.
Evaluate scope of job, interpret and understand customer requirements on job work ticket including all materials to be used.
Identify and communicate areas of improvements for quality control to QA Lead & Quality Assurance Manager.
Will comply with all current and future security and compliance requirements.
Participate in team brainstorming exercises to problem-solve and develop procedures.
Qa Auditor (Crew D) Ontario, Or
By Simplot At , Ontario, 97914, Or
Ensure that additional accountabilities required by management are handled in a manner necessary to meet operational standards.
Conduct product grading, sensory evaluation and analytical procedure training to hourly and management personnel.
Manage operator and technician proficiency program.
High school diploma or general education degree (GED)
Must obtain Sensory Grading Certification within 2 months.
Ensure self-compliance with Company policies and plant procedures, and the Collective Bargaining Agreement.
Qa Final Review Auditor
By Comav Technical Services Llc At , Victorville, 92394, Ca
5 Years heavy jet commercial experience
Methodical approach to task requirement
Able to make and utilize qualification rosters.
Perform final audit of maintenance documentation for:
Compliance to the approved data,
Verification of tooling calibration utilized,
Qa Auditor - Aerospace
By BSI At , Seattle, 98104, Wa $90,100 - $123,860 a year
Knowledge of management systems and auditing practices
Communication and Time Management skills
Responsible for managing a portfolio of assigned clients based on location and a match of qualifications and client contract requirements
College degree AA or higher (or equivalent certification or work experience)
AS9100 and ISO9001 audit delivery to our clients in support of 3rd party certification
Responsible for leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs
Qa Auditor Jobs
By The Smithers Group At , West Trenton, 08628, Nj
Prior CRO experience, Watson LIMS experience, and a general knowledge of GCP, GCLP, CLIA a plus.
Observes technical and professional staff for adherence to GLP and GCP requirements, GCLP standards, SOPs and related guidance.
Conducts internal facility and processes audits as required for compliance with regulatory requirements and SOPs.
Performs regulatory reviews of validation and qualification SOPs.
Assists or perform other job duties as assigned.
Must have excellent written and verbal communication skills.
Qa Auditor 2 (Hybrid) Jobs
By Q² Solutions At , Austin, 78759, Tx
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES
Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
MINIMUM EDUCATION REQUIRED AND EXPERIENCE
Present educational programs and provide guidance to operational staff on compliance procedures.
Qa Auditor Jobs
By BioAgilytix At Durham, NC, United States
Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks
Assist in document management activities
Perform duties with minimal QA Management oversight
Not less than two (2) years’ experience working in a laboratory/bench role/operations
Not less than three (3) years’ experience in GLP/GCLP/GMP quality assurance (QA)
Experience working in biotech, pharmaceutical, CRO/CMO or similar organization
Qa Auditor (Crew C) Ontario, Or
By Simplot At , Ontario, 97914, Or
Ensure that additional accountabilities required by management are handled in a manner necessary to meet operational standards.
Conduct product grading, sensory evaluation and analytical procedure training to hourly and management personnel.
Manage operator and technician proficiency program.
High school diploma or general education degree (GED)
Must obtain Sensory Grading Certification within 2 months.
Ensure self-compliance with Company policies and plant procedures, and the Collective Bargaining Agreement.
Qa Analytical Data Reviewer/Auditor
By Saptalis At , Hauppauge, 11788, Ny
Assist Management team during Pre-Approval and general GMP inspections by the USFDA and external auditors.
At least 2-5 years of testing and data review and cGMP experience
Knowledge of HPLC/GC principles and ability to review data for accuracy and completeness
Experience in quality systems auditing (internal and/or external) preferred
Knowledge of cGMP regulations and validation principles
Well-developed communication and technical writing skills
Qa Auditor 1 (Wfh/Remote)
By IQVIA At , Parsippany, Nj
Assume the role of system owner and administrator of the electronic quality management system (SmartSolve).
Assist in preparing Management Review Presentations, hand-outs, and supporting documentation
Familiarity with Quality Assurance and Quality Management Systems
Ensure that all procedures are reviewed and updated at least annually per internal requirements
Two years of experience with SmartSolve suite of products
Strong verbal and written communication skills in English
Qa Auditor - Ehs-Chicago
By BSI At , Chicago, Il $91,000 - $123,860 a year
Generic knowledge of management system auditing practices
Responsible for managing a portfolio of assigned clients based on location and a match of qualifications and client contract requirements.
College degree AA or higher (or equivalent certification or work experience)
Responsible for leading teams, when necessary, and mentoring and coaching new or inexperienced colleagues as needed to meet the business needs.
Third party audit experience in ISO 9001, ISO 14001, OHSAS 18001, RC14001 and RCMS
Knowledge of general office practices, information systems, documentation systems, and technology including computers
Qa Pv Auditor Jobs
By Barrington James At United States
Conduct audits of the pharmacovigilance systems and processes to ensure compliance with regulatory requirements and company standards.
Review and assess adverse event reports to ensure compliance with regulatory requirements and company standards.
Evaluate the effectiveness of pharmacovigilance processes and systems, identify gaps and make recommendations for improvements.
Ensure that pharmacovigilance activities are conducted in accordance with applicable regulations and guidelines.
Develop and maintain audit plans, schedules, and reports.
Work collaboratively with the pharmacovigilance team and other departments to ensure a comprehensive approach to drug safety.
Qa Auditor Jobs
By Veterans Alliance At Austin, TX, United States
Evaluate Internal Operations for adequacy of facilities, equipment, procedures, and overall management to ensure safe, effective, and compliant operations.
Works with management on yearly audit planning
Understanding of Safety Management System (SMS) and Root Cause Analysis (RCA)
Able to interface in a pleasant and professional manner with all departments, levels of management, customers, and vendors.
Perform other duties as assigned by the Quality Assurance Manager
Minimum of five (5) years of CFR Part 145 repair station or 121 air carrier quality assurance experience