Quality Assurance Specialist

  A great opportunity has opened as a Quality Assurance (QA) Specialist at our Round Rock location. In this role you 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. Specific job duties include: 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 methodsPerform 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 accuracyGenerating and review Certificate of Analysis (CoA) for catalog and custom projectsAssist in preparation and hosting external audits including customer, ISO, and DEA auditsGenerate quarterly metrics summarizing documentation review and production activitiesPerform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirementsRegularly 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 documentsAssist with internal audits as needed to maintain audit scheduleSupport rollout of local and corporate initiatives Who You Are: Minimum Qualifications: Bachelor's Degree in Chemistry, Biology, or other Life Science Discipline        OR High School Diploma or GED5+ years of experience in an ISO environment Preferred Qualifications: Working knowledge of quality system requirements of the pharmaceutical and/or clinical industriesPrior work experience in an ISO, or similarly regulated environmentKnowledge of ISO 9001, ISO 17025, ISO 17034 and ISO 14001Strong technical knowledge base and the ability to comprehend and communicate basic technical conceptsAbility to communicate effectively with all levels within the organization and with outside contactsSelf-motivated with the ability to work independentlyAbility to critically review documents for discrepancies with written procedures and requirements