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Quality Systems Specialist Jobs

Company

Regeneron
Address , Troy, 12180
Employment type
Salary
Expires 2023-09-20
Posted at 8 months ago
Job Description

JOB DESCRIPTION

We are currently looking to fill a Quality Systems Specialist position. This role creates and reports Deviation and CAPA metrics and leads or participates in continual improvement initiatives associated with the Quality Management System (QMS).


In this role, a typical day might include the following:

  • Assisting with or conducting assessments to ensure systems are effective and efficient, well designed and integrated with other QMS elements
  • Participation in daily operational activities such as monitoring status of system records, assisting users and record owners, and data trending for reporting metrics and for use in identifying continuous improvement initiatives.
  • Review of system records for assignment and closure.
  • Assisting Senior Quality Systems employees in support of maintaining, monitoring and improving quality system elements. This may include support in:
  • Assisting with the delivery of training, such as scheduling training sessions, maintaining rosters and collecting feedback.
  • Maintaining training content
  • Monitoring process performance over time
  • Assisting in audits and inspections.
  • Authoring and/or revising SOPs.
  • Leading or participates in continual improvement initiatives.


This role may be for you if you:

  • Have a broad knowledge of quality and cGMP principles and systems and relevant regulatory guidelines.
  • Enjoy both work in a team and in an individual capacity.
  • Excel at written, oral and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences.
  • Are organized and have strong attention to detail.
  • Excel in time and project management skills with the ability to manage many diverse tasks simultaneously.

To be considered for this role, you must hold a Bachelor’s degree in Life Sciences, Engineering, or related field and the following minimum amounts of relevant experience for each level:

  • Specialist – 2+ years
  • Senior Specialist – 5+ years
  • Associate Specialist – 0-2+ years

#REGNQA


Does this sound like you?to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.


Salary Range (annually)

$55,700.00 - $121,300.00