What are the responsibilities and job description for the QA Specialist II position at TalentBurst, an Inc 5000 company?
QA Specialist II
Houston, TX
06 Months
Job Description Summary *
Provide a brief (3 - 4 sentence) description that states "why” the job exists and describes the nature and level of work. The QA Specialist Level II-Quality Operations represents the QA department ensuring that quality requirements are met. Support manufacturing operations and all support groups related to manufacturing execution. Supports investigations using problem solving tools. Supports corrective actions and change controls as needed. Review and approve GMP master documents and executed GMP documents from QC, manufacturing, material management, and any other department that supports lot production. Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance. Job Description *
(Key Accountabilities)
Define all key accountabilities (5-10), which the role will be expected to perform in short to medium future. Make sure that you list the accountability on top, which the role will be doing most frequently and which has most impact on the the team/BU/Lonza. Begin each sentence with an action word, e.g. Provides appropriate coaching and performance feedback to all direct reports.
- Verify the company's compliance with ISO/GMP quality system requirements and other regulatory guidance as appropriate.
- provide oversight for compliance of CAPA and minor deviations.
- Perform QA walkthroughs and work closely with manufacturing and support groups to resolve any issues identified during the walkthroughs.
- Support activities that involves QA presence on the floor.
- Review Master Batch Records (MBR) and supporting documents to support batch disposition. Perform review/release of Buffer/ media as needed.
- Perform other duties as assigned.
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