Quality Assurance Specialist
Avantorinc
Mexico City
hace 2 días

Job Summary

The Quality Assurance Specialist ensures that all processes contributing to the performance of the quality system are implemented and maintained in Mexico business unit.

He / she is responsible for all activities involving quality assurance, and compliance with applicable regulatory requirements.

The focus of the position is to develop, perform and manage quality assurance related activities such as responding to customer complaints, management of intranet QA sites and overall compliance to ISO 9001 : 2015 standards and other related standards.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

  • Responsible for the continual improvement of the Quality Management System of VWR Mexico.
  • Establishes, coordinates, and monitors the Quality Management System for VWR Mexico Unit.
  • 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 required. Reviews and approves report of analytical results / Certificate of Analysis for compliance evaluation.
  • Create and develops or approves standard operating procedures for VWR Mexico 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 for VWR.
  • Develops and executes internal audits program. Identifies and generates corrective action plans, provide follow ups and communicate results to management.
  • In charge of the internal and external audits. Answers 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 VWR Mexico 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 suppliers. Must 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 (Education / Training, Experience and Certifications)

  • Bachelor’s degree in science, chemistry or engineering strongly preferred
  • Three to Five years’ experience the pharmaceutical or manufacturing industry
  • Bilingual (Spanish and English), a must
  • KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

  • 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

    environment. The 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 gases.

    Physical effort is required. Work 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 fumes. Personal protective equipment required (safety shoes, respirators, gloves, safety glasses and laboratory coats required.

    DISCLAIMER :

    The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.

    They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

    Avantor is proud to be an equal opportunity employer.

    EEO Statement

    We are an Equal Employment / Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state / province, or local law.

    If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement vwr.

    com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.

    Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

    For more information about our commitment to equal employment opportunity, please Privacy Policy(Links to (1) EEO is the Law poster and any supplements, (2) pay transparency nondiscrimination statement, and (3) if desired, Company EEO / AA Statement

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