A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
The Quality Systems Specialist I will manage and analyze the reporting of the sites Deviation, CAPA and Change Control systems. Other job duties may include document harmonization process, support to the customer and internal audit processes, as well as Quality Systems related to validation and Risk Management.
Management of system metrics, implementation of quality assurance process improvements within Production and Quality departments, including the development of procedures to provide quality guidance and methods is expected. The candidate will understand and apply ISO 9001 Quality Systems Management, concepts and practices.
Who you are:Minimum Qualifications:
- Serve as the Site Lead User (SLU) for TrackWise Deviation/CAPA system to manage the database and provide periodic reports as needed for operations and quality. Analyze trends to generate and present quarterly reports for site leadership. Coordinate with deviation record owners to assure compliance and best practices are maintained for effective root cause analysis and eliminate recurrences.
- Coordinate training for new hires in the TrackWise Deviation/CAPA module as needed.
- Serve as the TrackWise Change Control SLU with similar responsibilities as Deviation/CAPA.
- Provide training in Root Cause Investigations & Effectiveness Checks of Nonconforming Incidents.
- Coordinate Document Harmonization efforts
- High School Diploma or GED equivalent
- 3+ years experience in a manufacturing environment
- 1+ years experience utilizing Microsoft Office, Trackwise and Mango Software applications
- Bachelor of Science degree in Engineering, Life Sciences, or related discipline
- Experience working as a Quality Technician
- Excellent communication skills, both written and oral, ability to collaborate and influence at all levels and functions of the organization and with customers.
- Experience with SAP ERP
- General knowledge of ISO 9001:2015 principles and working knowledge of CAPA and Change Control systems.
- Self-directed and self-motivated
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: 213952
Career Level: C - Professional (1-3 years)
Working time model: full-time
This job has expired.