13 days old

Compliance Technician II

CooperVision
Juana Díaz, PR
  • Job Code
    JUA1029
CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the worlds leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com


JOB TITLE: Compliance Technician II

DEPARTMENT: Quality- Regulatory

JOB SUMMARY
Under the direct supervision of the Sr. QA/ RA Cell Leader the Compliance Technician II will perform activities related to documentation such as:


ESSENTIAL FUNCTIONS

  • Assign tracking number to SOPs, protocols, DCR, and deviations.

  • Revise SOPs format.

  • Assist initiators on SOPs requirements/cross reference/deviation.

  • Distribute/retrieve official documentation as applicable.

  • Maintain and update electronic and manual documentation files.

  • Maintain good recordkeeping of SOPs and Quality Records.

  • Prepare monthly reports as requested.

  • Receive, file and retrieve Quality Records.

  • Maintains procedures and complaints workflow

  • Revise procedures when required.

  • Support on Improvement Projects.

  • Develop reports for Management Review/Complaint Meeting/other corporate matters as required.

  • Assist Sr. QA/ RA Cell Leader when required.

  • Assist Quality Improvers / Training Area as requested.

  • Train new hires on GDP & GMP procedures.

  • Responsible of the Software process (previously owned by Engineer Group)

  • Documents / Procedures translations

CooperVisions management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory andregulatory requirements.

POSITION QUALIFICATIONS
KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of computer systems (Microsoft Excel, Word, Power point, BPCs, Agile).

  • Works under minimum supervision.

  • Comply with the companys attendance policy.

  • Good oral/written communication skills in both English and Spanish

WORK ENVIRONMENT

  • Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature.

  • Needs to stand, walk and may be seated for a long period of time.

  • Uses hands to handle and reach.

  • Could be required to travel.

  • Works with a personal computer and programs to prepare documents or reports.

  • Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others.

  • Needs to have high analytical capacity and level of professionalism and judgement to resolve problems.

EDUCATION

  • Bachelor Degree or equivalent experience.



EXPERIENCE



  • One or two years of experience quality documentation


The above statements are intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities. CooperVision, Inc. reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.





Posted: 2019-10-31 Expires: 2019-11-29
Sponsored by:
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Sponsored by:
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Compliance Technician II

CooperVision
Juana Díaz, PR

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