Quality Systems Specialist I
MilliporeSigma

Kankakee, Illinois

Posted in Science and Research


This job has expired.

Job Info


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.

Your Role:

Oversees the Deviation and CAPA system to ensure adequate investigation performed utilizing root cause analysis and risk assessment tools and subsequently implementing effective corrective/preventative actions.Executes, maintains, and continually evaluates quality assurance and/or control methods and systems. Utilizes standards and procedures to provide quality guidance and methods.

  • Supports the investigation of customer complaints through batch record review, trend analysis and CAPA evaluation
  • Support the Supplier Quality Management (SQM) system through supplier evaluation (i.e. survey analysis, supplier quality audits, supplier risk assessment)
  • Support Internal Quality Audit (IQA) program through completion of internal audits according to audit schedule
  • Manufacturing support through statistical analysis, CAPA investigations, complaint investigations, and validation support
  • Oversee the CAPA system to ensure effective corrective and preventive actions are implemented to prevent reoccurrence
  • Oversee the change control system to ensure effective execution of change control activities
  • Execute documentation revisions and approvals within the electronic documentation database
  • Assist validation by reviewing protocols, execution of protocols, reviewing / writing of final reports
  • Provides monthly quality indicators and improves results
  • Apply the requirements fixed in the Quality Assurance and ensure that the procedures are followed Apply the safety requirements. Be involved in customer audits for systems engineering and manufacturing plant, keep the general specifications up to date
  • Ensures that the ISO, cGMP, and USDA guidelines and corporate policies are followed. Respects the factory safety rules

*Travel by car and/or plane, up to 25% based onbusiness need.

Who You Are
Minimum Qualifications:

  • Bachelors Degree in Science discipline (i.e. Chemistry, Biology, or MedicalTechnology)
  • 3 years experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance position

Preferred Qualifications:
  • Project management experience is a plus
  • Demonstrated experience in development and management of CAPA, Change Control, and document control systems.
  • Demonstrated experience with internal and external audit processes.
  • Demonstrated expertise in cGMPs, ISO 9001,and SOP development.
  • Demonstrated basic computer skills and a working knowledge of basic computer software (Microsoft Office,MiniTab).
  • Six Sigma training/certification a plus.
  • Certified Quality Auditor (CQA) is a plus

RSMS

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.

Job Requisition ID: 223296

Location: Kankakee

Career Level: C - Professional (1-3 years)

Working time model: full-time


This job has expired.

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