Quality Assurance Specialist at Millipore Corporation in Round Rock, Texas

Posted in Other 10 days ago.





Job Description:

MilliporeSigma has an opening as a Quality Assurance (QA) Specialist at our Round Rock location. The Quality Assurance Specialist will efficiently review and release quality production documents ensuring QA activities are aligned with quality documents and procedures in addition to customer and market requirements.



Responsibilities:



Coordinate and perform review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications, and methods.Perform document record review and approval of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.Generate and review Certificate of Analysis (CoA) for catalog and custom projects.Assist in the preparation and hosting of external audits including customer, ISO, and DEA audits.Generate quarterly metrics summarizing documentation review and production activities.Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.Regularly communicate with the QA management any problems and concerns that may delay or lead to the failure of the completion of projects, qualifications, validations, or other quality documents.Assist with internal inspections as needed to maintain the audit schedule.Support implementation of local and corporate initiatives.



Who You Are:




Minimum Qualifications:



Bachelor's Degree in any field and 1+ year of experience in a GMP, GLP, FDA, ISO or other regulated environment -OR-High School Diploma or GED with 5+ years of experience in a GMP, GLP, FDA, ISO or other regulated environment



Preferred Qualifications:



Bachelor's Degree in Chemistry, Biology or other Life ScienceKnowledge of ISO 9001, ISO 17025, ISO 17034, and ISO 14001Knowledge of quality system requirements of the pharmaceutical and/or clinical industriesExcellent communication skills. The ability to respond to colleagues effectively, both verbally and in writing.The ability to interact and work well with other team membersAbility to approach others to discuss work-related items in a manner that will allow for a successful outcomeStrong technical knowledge base and the ability to comprehend and communicate basic technical conceptsSelf-motivated and able to work independentlyAbility to critically review documents for discrepancies with written procedures and requirementsRSREMD


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