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.
This position is responsible for maintaining quality management systems, including but not limited to, customer complaints and labeling software, as well as implementing Quality Assurance processes and improvements within Production and Quality departments. The candidate will conduct root cause analysis in relation to audit observations, nonconformance, and complaints. Develop procedures to provide quality guidance and best practices. Requires understanding and application of ISO 9001 concepts and practices. Reports to the Quality Assurance Supervisor
ESSENTIAL JOB FUNCTIONS
- Maintain Customer Complaint quality system including Investigation and Field Corrections
- Work with various manufacturing and other functional teams to complete Root Cause Analysis and CAPA investigations
- Site SME for Labeling Software – support trouble shooting issues and validation on upgrades.
- Conduct internal audits
- Conduct site Quality System Training
- Write, review or approve Operation Procedures, Specifications, Master Manufacturing Procedures and other QA-controlled documents.
- Participate in Process Improvement teams for Quality System related initiatives/projects.
- Develop effective and collaborative working relationships with other departments including Planning, Purchasing, Manufacturing, R&D and Operations.
Who You Are
- Quality systems experience, including ISO 9001:2015
- Excellent oral and written communication skills. Ability to work and communicate effectively with all areas and levels of the organization.
- Demonstrated ability to work independently as well as in a team environment.
- Ability to multi-task and establish priorities is important
- Proficient in software applications; Word, Excel, PowerPoint
- B.S./B.A. in Life Sciences, Chemistry, Biology, Pharmacy, Chemical or Process Engineering and 1-3+ years’ experience in industry preferred.
- A non-science, 4-year degree with at least 5 years applicable Quality System (i.e. ISO environment) experience in the specific QA job function as deemed appropriate by QA Management required.
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.