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.
Support the maintenance, development and improvement of Quality Systems, such as auditing (internal, supplier and customer), training, process validation, vendor management, cleaning validation, equipment qualification, change control, complaint handling, and documentation control. Ensure that analytical aspects of product release meet specifications in accordance with established quality systems.
Essential Job Function
- Process Improvement, NCR and CAPA Systems
- Actively participate in the development, implementation and improvement of Quality Systems.
- Routinely support and recommend ongoing process improvements with the department and the organization, ensuring efficient and value added processes.
- Lead and participate in work with Production, QC, Purchasing, Packaging and Materials Management to resolve issues with product releases and failure investigations. Work closely with production and R & D to implement process changes based upon investigation conclusions.
- Oversee Corrective and Preventative Action system to ensure appropriate investigations are performed and resolution is achieved in a timely manner.
- Assist with complaint handling and investigations.
- Interact with customers and implement quality systems
- Review customer requests for product agreements pertaining to product specifications, testing protocols, label and documentation requirements.
- Respond to quality-related customer questions.
- Coordinate the resolution and completion of customer complaints pertaining to quality and process related issues.
- Technical and regulatory reviewer for documentation and protocol changes
- Assist in the development of experimental protocols for product or process validations, stability studies, and expiry date studies.
- Manage stability studies for internal products and customers.
- Coordinate and/or execute equipment qualification activities pertaining to processing and cleaning within the Quality Control Department and perform/oversee instrument initiation and IQ/OQ activities on new equipment.
- Maintain the schedule for instrument calibration.
- Coordinate the execution of validation sampling in accordance with approved protocols.
- Coordinate consultative efforts to ensure timelines are met.
- Communication and training
- Present various quality systems training topics such as updated operating procedures and quality requirements to laboratory and quality personnel on a monthly basis.
- Interact with the R & D, technical transfer, planning & scheduling, production and laboratory personnel regularly to ensure adequate communication and feedback for quality-related services to internal customers.
- B.A./B.S. in Life Sciences, Pharmacy or Chemical Engineering or a non-science preferred
- 4 years experience in the specific QA/QC job function as deemed appropriate by QA/QC Management
- 4 years experience in quality assurance, or other functional areas specific for the available position
- Advanced degree in Chemistry, Biochemistry, Biology, Pharmacy or Engineering or BusinessManagement desired
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill 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!
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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.