Quality Systems Specialist

at MilliporeSigma
Location Sheboygan Falls, Sheboygan Falls, Wisconsin
Date Posted October 30, 2020
Category Bioscience
Job Type Full-time
Address Sheboygan Falls


Your role:


You will ensure that all aspects of product manufacturing and release meet analytical, production, packaging and labeling specification in accordance with established quality systems. Support the manufacturing, maintenance, development and improvement of GMP and/or ISO-9000 quality systems, such as auditing (internal, supplier, and customer), training, change control, complaint handling, and documentation control Provide Quality system support for Sheboygan and Milwaukee manufacturing operations. Support quality systems for other sites globally when needed.


Vendor and Production documentation - Support generation of MPR's (master production records) to be used in manufacturing of products. Support in creating systems for assigning Key Control and Monitoring parameters based on Change Control guidelines and MPR generation template
Update MPR template for include key quality components such as RFC flow chart revision history etc. Review collect and analyze manufacturing process data. Review for approval supplier RMQs (raw material questionnaires) on products
Customer quality questionnaires and complaint investigations – Complete quality questionnaires as requested by customers. Enter and assist in investigation of quality notifications and complaints. Assist in the entering and investigation of supplier-related CAPA’s
Support Internal and External Audits – Support and assist with customer and regulatory compliance audits involving facilities and/or quality systems. Summarize customer and product related complaints from SAP as part of continual process improvement efforts. Support vendor audits by compiling historical documentation of quality documents and complaint history
Training Database Support – Assist with design and configuration of employee training database. Act as technical resource to answer questions and solve problems related to database operation. Conduct training to ensure consistent and efficient use of the database
SOP Database Support – Maintain documents in corporate database. Configure database for document organization per business requirements. Act as technical resource for database operation and maintenance
Learn Jump, Minitab, or other data analysis programs for correlation activities

Who You Are:

Basic Qualifications:


Bachelor of Science or Bachelor of Arts degree in Science, Engineering, Business or Mathematics, Chemistry or other Life Sciences discipline
3+ years of work experience in a chemical manufacturing setting
1+ years of work experience in quality control or quality assurance
1+ year of direct manufacturing experience
1+ year of quality and training experience
1+ year of current experience utilizing Good Manufacturing Practices and ISO Quality Systems

Preferred Qualifications:


1+ year of customer service or customer interaction work experience


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