Qa Reviewer Jobs

QA Reviewer
Contract
Coral Springs, FL
Role Summary:
Review manufacturing batch records, analytical reports and related documentation to ensure that products meet release requirements, and to identify areas of opportunity and quality improvements. Inform QA when documentation and processes are not within compliance to take appropriate actions.
Essential Duties and Responsibilities

• Communicate effectively with cross functional departments to ensure on time delivery of corrections, QA review and disposition responsibilities.
• Keep track of data and records review indicators for internal quality metrics and annual product review.
• Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, create and revise relevant SOPs.
• Accordance with good documentation practices (GDP), product specifications, process parameters and regulatory requirements.
• Review of environmental monitoring data, microbiology and cleaning testing results.
• Provide the required support during regulatory and internal audits.
• Review of Quality events, incidents and deviations related to manufacturing processes, and to Laboratory testing, OOS, OOT, and OOE investigations.
• Review of executed batch records and all related documentation for manufacturing activities in
• Compile and review all applicable documentation for batch review and release, keep track and oversee status of batches to ensure all QA batch disposition deadlines are met.
• Review all tests results, generated in support of testing of raw materials, in-process, finished product and stability samples including, but not limited to, assays, chromatographic purity, content uniformity using HPLC/UPLC, particle size distribution, density, water determination, and other tests according to the in- house monographs and USP and other compendia in a regulated laboratory environment.
• Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices.
• Review of analytical reports to ensure that products, material, components and intermediates meet company standards and regulatory requirements.
• Perform additional tasks as assigned by the QA supervisor.

Education & Experience

• Previous experience using analytical instrumentation, software, and tests performed in the lab, including: HPLC, GC, Dissolution, Raw Materials, etc. is preferred.
• Understanding of SOPs, STPs, USP/NF, GLP, ALCOA and data integrity procedures, guidelines and requirements.
• 1+ year batch record and analytical data review experience required.
• 4+ years’ experience within the pharmaceutical, biologic, medical device or regulated industry.
• 2+ years’ experience in a Quality Assurance/Quality Control or Manufacturing function.
• Bachelor’s degree in Life Sciences discipline.

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