Job details
Job type full-time number of hires for this role 1
Full job description
Job summary
The quality auditor works closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelinesResponsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendlyInterpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleaguesDevelop and execute test plans to ensure that all objectives are met.
Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or productIdentify and remedy defects within the production process.
Location: remote/virtual but must be able to travel domestically and internationally.
Major job duties and responsibilities:
Responsible for the continual improvement of the quality management system.
Establishes, coordinates, and monitors the quality management system.
Works closely with managers and supervisors to plan, schedule and implement qa related activities.
Plans, develops, and implements quality assurance programs for vwr mexico business units.
Prepares routine and special reports to staff, and regulatory agencies as required.
Implement correction action in processes as requiredReviews and approves report of analytical results/certificate of analysis for compliance evaluation.
Create and develops or approves standard operating procedures for business unit.
Serve as document owner responsible of document creation (sop, work instructions, etc), maintenance, and compliance for processes where qa specialist is knowledgeable.
Prepares and/or maintains computer programs for the compiling and statistical analysis of quality assurance data.
Develops and presents training program as gmp and gdp.
Develops and executes internal audits programIdentifies and generates corrective action plans, provide follow ups and communicate results to management.
In charge of the internal and external auditsAnswers customer and suppliers audits completely and timely.
Collect, analyze, and document objective evidence as required in the assigned audits.
Ascertain whether or not procedures, documents or other information describing or supporting the quality systems are known, available and dues by associates.
Evaluates quality events, investigations, discrepancies, noncompliance issues (scar’s), corrective and preventive actions reports and possible complaints.
Identify correction actions in procedures and processes.
Manages and maintains databases for the quality system and prepares a quality trending reports.
Participate in quality and planning meetings and applicable corrective action team activities.
Develops and implements a coordinated applied program for business unit quality assurance; writes clear and concise reports; works with a variety of managers and supervisors to plan, schedule, organize and coordinate the quality assurance program.
Performs standard quality assurance/quality control evaluation procedures, evaluating data using statistical methods for analysis, interpreting results of analysis, and making appropriate recommendations to management in developing and presenting a variety of training programs and preparing manuals and documentation.
Formulates and maintains process validation, qc objectives based on company vision and objectives.
Interacts with associates, clients and suppliersMust be affable and warm maintaining and guarding for an atmosphere of cooperation, teamwork and respect even in moments of stress.
Complete audit paperwork as defined and required.
Performs other duties as assigned.
Qualifications:
Bachelor’s degree in science, chemistry or engineering strongly preferred
Three to five years’ experience the pharmaceutical or manufacturing industry
Knowledge skills and abilities:
Knowledge in gmp, glp, gdp and iso regulations
Experience creating, maintaining and auditing quality program
Certified in quality program, preferable
Microsoft office (excel) skills, intermediate level
Environmental working conditions & physical effort (under typical positions):
The work environment characteristics and physical effort described here are representative of those an associate encounter while performing the essential functions of this job.
While performing the duties of this job, the associate is exposed to an industrial warehouse
EnvironmentThe associate works near moving mechanical machinery and moderate noise level.
The job requires working in heights, exposure to changes in temperature, driving equipment, and maybe exposed to dust, fumes, or gasesPhysical effort is requiredWork require walking, standing,
Bending, reaching, lifting or carrying objects that typically weigh more than 25 lbs.
Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.
Associate may be exposed to areas with penicillin, aspirin, alcohol, acetone and other fumesPersonal protective equipment required (safety shoes, respirators, gloves, safety glasses and laboratory coats required.
Traveling required.
Job type: full-time
Schedule:
8 hour shift
Work remotely:
Yes
Work location: multiple locations
