Qa Specialist I

• Team environment
• Batch Record Review area

• Bachelor's Degree in Science (preferably on Biology, Chemistry or Biotechnology) or Engineering.

• Knowledge and experience in manufacturing of biotechnology products and GMPs is needed, and in aseptic processing is preferable.

• Experience working in highly computerized Operations environments– 1 Year

• Experience working in a Biotechnology Manufacturing Plant in areas of quality, or manufacturing – 2 Years

• The candidate must be proficient in the English language.

• Audit API and/or finished Drug Product electronic and manual (paper) batch records to assure compliance with applicable GMPs, policies, procedures and guidelines.
• Able to approve MES exceptions related to production support worksheets and perform Quality Hold (as required).
• Document recommendations for deviations from approved procedures and specifications to assure the capability of meeting product quality requirements prior to release.
• Evaluate all deviations documented in batch records and determine the need for a corrective action.
• Track/trend batch record discrepancies per procedural requirements and work with other departments (e.g. Manufacturing, Tech Ops, MS&T, MQA) to evaluate the discrepancies to establish necessary actions to reduce errors.
• Review of the manufacturing process and related equipment and facilities to assure compliance with procedures, specifications, and policies.
• Give timely disposition to materials in the SAP system based upon result of testing and compliance with Regulatory Agency requirements.
• Prepare certificate of analysis and certificates of compliance for API and/or finished Drug Product.
• Enter required batch information into the lot restriction management system.
• Assemble the batch record review package and label per the approved retention procedures.
• Prepare reports including Right the First Time, Release Cycle Time and Regulatory Audits requests. Revise procedures as required.
• Generate lot lists for the Product Quality Review.
• Coordinate and participate in weekly meetings with Manufacturing and QC Labs personnel to discuss batch record discrepancies and/or issues that may impact batch release.
• Act as contact person for projects as required.
• Demonstrates accountability and responsibility of EHS performance and compliance.
• Creation and removal of QA Hold condition in SAP system.

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