Job Description

Qualifications:

• Bachelor's Degree in related field
• 1-2 years of experience in pharmaceutical manufacturing
• Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate

Job Description:

The QA Specialist Demonstrates sufficient depth of knowledge within own work area in order to perform hands-on routine QA tasks. This role supports Operations including batch record, investigation, and document review, and disposition activities. Resolve routine quality issues related to product manufacture and testing with guidance/coaching. Project work, as needed, will also be expected. Other essential duties and responsibilities in quality assurance include:

• Provide Quality Assurance expertise to colleagues On and off the Manufacturing floor as required.
• Identify continuous improvement opportunities based on metrics and drive consistency through the process to align with standard processes and quality systems.
• Conduct regular Production areas walkthroughs (Area product clarences, GMP and compliance walkthroughs)
• Conduct On floor QA review of executed batch records and Logbooks to assure compliance with regulatory standards and regulatory filing.
• Assist Quality Operations Deviations and Product Floor Support for all planned and unplanned manufacturing deviations.
• Escalate issues as appropriate to the Quality Assurance Management in a timely manner.
• Maintain regulatory compliance in accordance with current Good Manufacturing Practices.
• Accurately communicate Supply/Operational needs/perspectives as well as Quality Operations (QO) perspectives.
• Quality Assurance approval of SOPs, Campaigns start up Form and QA validation protocols and reports.
• Maintains inspection readiness and supports internal/external audits as needed.
• Interface with Regulatory Agencies in audits.

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