A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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.
Support the Quality needs of the Cleveland site by supervising routine QA activities. Oversee and support the QA department, with responsibilities including: maintain and improve Cleveland Quality Systems, such as auditing (internal, supplier and customer), training, validation, supplier management, change control, complaint handling, and NCR handling. Disposition finished product by evaluating all aspects of product versus analytical, production, packaging and labeling specifications in accordance with established procedures.
- Actively participate in the 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.
- Oversee Corrective and Preventative Action system to ensure appropriate investigations are performed and resolution is achieved in a timely manner.
- Ensure restriction of non-conforming products from sale as needed and ensure all necessary personnel (internal and external) are notified. Lead / assist with recalls and field corrections as needed.
- Assist with complaint handling and investigations.
- Review customer requests for product agreements pertaining to product specifications, testing protocols, label and documentation requirements.
- Coordinate the resolution and completion of customer complaints pertaining to quality and process related issues.
- Review and approve Quality System Documents.
- Represent MilliporeSigma Quality Systems during customer audits.
- Follow-up with areas to ensure completion of corrective action tasks within the specified timeline.
- Trend internal and external audit observations, create reports summarizing areas that are deficient, and provide recommendations for improvements.
- Present various quality systems training topics to production, laboratory and quality personnel.
Who You Are:
- Bachelor’s Degree in Life Sciences, Pharmacy or Chemical Engineering and 6+ years of QA experience
- Bachelor’s Degree in any discipline and 10+ years of QA experience
- QA role in a chemical or GMP regulated manufacturing environment
- Prior experience in a GMP environment
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.