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QA Specialist

Quality Assurance Specialist


Your Role:

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

Product disposition

  • 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:

Basic Qualification:

  • B.S./B.S. in Life Sciences, Pharmacy or Chemical Engineering
  • Non-science, 4-year degree

Preferred Qualification:

  •  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


Job Requisition ID:  189219
Location:  Cleveland
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Nearest Major Market: Cleveland

Job Segment: Pharmacy, QA, Quality Assurance, Healthcare, Quality, Customer Service, Technology

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