Quality Systems Specialist II

Posted 27 Sep 2018

Jaffrey, New Hampshire - United States

Req Id 182117

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 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.


POSITION SCOPE:

This position occurs during 1st shift operations.  This position is responsible for providing support to the customer and internal audit processes, oversight and reporting on supplier quality activities, maintain document harmonization with divisional policies, assist with data integrity and master data systems as well as Quality Systems related to validation and Risk Management.

Quality System Metrics and implementation of Quality Assurance processes and improvements within Production and Quality departments.  Conduct root cause analysis in relation non-conformances, audit observations, and complaints.  Develop procedures to provide quality guidance and methods.  Requires understanding and application of ISO 9001, and FDA GMP principles, concepts and practices.

ESSENTIAL JOB FUNCTIONS:

  • Customer audits, provide support to audit host, coordinate audit requests, serve as alternate audit host. Conduct internal audits, support regulatory and registrar audits. Assist in the maintenance of the audit observation database.
  • Provide site Supplier Quality oversight, monitoring requirements as specified, work with site SQE's and QM's to ensure compliance with supplier audits, supplier review board, quality agreements and other related supplier performance metrics. 
  • Coordinate validation system activities to ensure control of records, identify risks and establish compliance to company policies.
  • Maintain Document Harmonization including write, review or approve Operation Procedures, Specifications, Master Manufacturing Procedures to ensure compliance.
  • Assist with Master Data and Data Integrity compliant systems.
  • Conduct Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents.
  • Interact with the R & D, Engineering, planning, production and laboratory personnel to ensure adequate communication and feedback for quality-related issues.

Who You Are:

Basic Qualifications:

  • Must have excellent communication skills, both written and oral, ability to collaborate at all levels and functions of the organization and with customers. The ability to influence and gain consensus with groups is a must.
  • Proficient use of Microsoft Office software.
  • 3 years minimum in FDA regulated industry (pharmaceuticals, biomedical, or medical device)
  • Experienced in customer, regulatory and internal QMS compliance audit programs preferred. 
  • Subject matter expert regarding FDA QSR 21 CFR 820 and ISO 9001:2015 principles.
  • Working knowledge of CAPA and Change Control systems.
  • Self-directed and self-motivated
  • Bachelors of Science degree in Engineering, Life Sciences, or related field preferred

 


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 come2emd.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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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