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.
Quality Assurance Specialist
Support the Quality needs of the Cleveland site by serving as a contact for routine QA activities and inquiries. Additionally, 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.
Hours are: Monday - Friday 8:00 AM - 5:00 PM
Essential Job Functions
- Review executed batch documentation to determine whether process and laboratory results meet the predetermined acceptance criteria for release.
- Report all process deviations and/or laboratory OOS results.
- Investigate pertinent process anomalies.
Quality System Improvement
- 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.
- 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.
- Restrict 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.
- Assist in the development of raw material specifications applicable to the final product requirements and subsequent review and approval of raw material lots.
- Assist with data integrity program development and implementation
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
- Review and approve all Quality System Documents.
Quality System Audits
- Represent Sigma-Aldrich Quality Systems during customer audits.
- Issue audit reports following supplier audits and track progress of supplier corrective actions.
- Maintain the database for customer audit observations and issue corrective action reports to the affection production/laboratory area.
- Follow-up with areas to ensure completion of corrective action tasks within the specified timeline.
- Coordinate and improve the internal and supplier audit program by conducting, reporting and tracking audit results.
- Maintain the database for internal audit observations, create reports summarizing areas that are deficient, and provide recommendations for improvements.
Communication and training
- Present various quality systems training topics to production, laboratory and quality personnel.
- 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.
Who You Are:
- B.S./B.S. in Life Sciences, Pharmacy or Chemical Engineering
- Non-science, 4-year degree
- QC role in a chemical or GMP regulated manufacturing environment
- Prior experience in a GMP environment
- 6 years of quality experience in QA
- If non-science degree, would prefer 10 years applicable QA experience in the specific QA job function
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!
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.