Specialist, Quality Assurance

Posted 30 Oct 2019

Bellefonte, Pennsylvania - United States

Req Id 198850

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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.


Your Role

Ensure that all aspects of product and service meet quality standards/ expectations.  Support the maintenance, development and improvement of the quality management system supporting site operations and ISO accreditations as well as other customer and/or regulatory requirements.  These systems would include auditing (internal, external, and vendor), training/employee development, validation, change control, customer complaint investigation, document control.
 

In this role you will review completed batch records for compliance; initiate and coordinate the Management of Change for product quality-related changes to documents, equipment, specs, and methods; participate in the internal/supplier auditing programs; issue reports after supplier audits; Maintain database for customer audits, issue corrective actions, follow-up for effectiveness checks.

Represent the company during customer/external audits, Monitor and trend results for critical quality processes, customer complaints, pass rates, etc.  Respond to quality related customer complaints/questions, and maintain customer ratings regarding quality.

 

Write and/or review documentation to ensure compliance to all standards or regulations; coordinate Validation activities; assist with oversight of calibration department; interact with the production and laboratory personnel frequently to ensure adequate communication and feed back for quality related services to internal customers.  Lead and participate in root cause and risk assessment activities related to process and product investigations and improvements.

 

You will also participate in Quality Training/Employee development; review and manage customer requests for product agreements and change control; maintain the quality actions and look for trends; lead and participate in process improvement projects related to the document control process for quality management system to gain efficiencies and to ensure effectiveness in supporting company quality goals.  Maintain and continuous improvement of department metrics. 

 

Physical Requirements:

  • Hearing and vision within normal limits. 
  • Ability to use PC frequently.

 

Who You Are:

 Minimum Qualifications:

  • Education: BS degree in Chemistry or related science, or Quality Assurance.
  • 2+ years quality experience
  • 1+ years of experience working on or leading process improvement projects

 

Preferred Qualifications:

  • Knowledge of ISO quality management system
  • Excellent interpersonal skills
  • Excellent problem solving skills
  • Ability to prioritize and organize
  • Good computer skills (advanced user of excel and word and relevant databases a plus)
  • Exceptional ability to learn and apply new concepts

 

ADDITIONAL LOCAL NEEDS

Office and laboratory environment.

RSRMS


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!

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


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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