Quality Manager Distribution

Posté 08 déc. 2021

Allentown, Pennsylvania - United States

Demander un identifiant 234839

Détails

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 


Your Role:

  • Provide Leadership for & be Responsible person all Quality topics at a distribution sites and related commercial subsidiary.
  • Implement and maintain the local QMS and GDP standards, if applicable.
  • Ensure feedback and information for Quality topics from and to LS-Q.
  • Ensure site is fully compliant to applicable ISO standards & GDP

 

Scope of responsibilities:

  • Local management of all aspects of the Quality Management System and Good Distribution Practices (GDP) requirements, if applicable to site of Life Science USA – Allentown and Canada.
  • Local representative for Quality Management/Quality Assurance for distribution operations & related commercial activities.


Essential Job Function:

  1. Supports the implementation of LS procedures and the company's requirements at the local level and remotely support Allentown QMS.
  2. Manages the documentation and records of the Quality Systems.
  3. Ensures the quality-training and communication of Quality topics on site and remotely support Oakville.
  4. Ensures proper application of key quality processes: Risk, Change Control, Complaint, Deviation, Audit and Supplier Management.
  5. Ensures ISO processes performance review and Quality Management Review.
  6. Coordinates local internal audits, LS-Q and EQ-Q Audits, external certification body audit, authority inspection and customer audits as well as supplier audits.
  7. Performs internal audits, if applicable.
  8. Develops and implements actions resulting from audits.
  9. Manages CAPA’s (addressing, follow-up). Remotely support Allentown.
  10. Manages and distributes relevant KQI as required.
  11. Is the authorized person to release returned products and to approve deviation on temperature excursion as described in global LS-Q procedures.
  12. Liaise closely with Regulatory Affairs & Trade Compliance team to ensure alignment and conformance with all requirements.

 

Hybrid working environment 

 

Who you are:

Minimum Qualifications:

  • Training (internal or external) in Quality Management and GDP.
  • Experience (3-5 years) in QA-related tasks.
  • IS0 9001 Quality Management System experience.
  • Good communication skills
  • Bachelors degree

 

Preferred Qualifications:

  • Working knowledge of a distribution operation.
  • Working knowledge of trade compliance and legal regulations for import/export.
  • Trained systems auditor.
  • Team Building, Development & Motivational skills.
  • Fluent English.
  • Availability to travel.

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

Curious? Apply and find more information at https://jobs.vibrantm.com

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

 

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