QA Batch Record Release Specialist 2

The QA Specialist II will provide essential Quality Assurance (QA) support to Quality Operations, with a primary focus on material and batch release activities. In a fast-paced pharmaceutical environment, the successful candidate will leverage strong documentation, organizational, and communication skills to ensure compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. This role requires a detail-oriented individual with the ability to assess and maintain the quality of materials, products, and processes.

Essential Duties & Responsibilities:

• Maintain GMP Databases: Ensure accurate and consistent tracking, data entry, and follow-up within departmental GMP databases.
• Review Manufacturing and Analytical Records: Evaluate completed manufacturing, filling, labeling records, and analytical data to ensure conformance with applicable regulations, Standard Operating Procedures (SOPs), specifications, and acceptance criteria.
• GMP System Procedure Review: Regularly review and update GMP system procedures to ensure alignment with current regulatory standards and company policies.
• Monitor Production Activities: Perform hands-on monitoring of production and non-production activities, identifying and reporting any observed non-compliance to Quality Management.
• Product Compliance: Ensure that finished products conform to both government and company standards while meeting cGxP regulations.
• Batch and Material Release Documentation: Prepare and conduct initial reviews of documentation for the release of acceptable product lots and vendor materials.
• Deviation Investigation Support: Assist in investigating deviations, identifying root causes, and proposing corrective actions.
• SOP, Change Control, and Protocol Review: Review and provide input on SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
• Quality Metrics Reporting: Report key quality metrics and performance indicators as required.
• Audit Participation: Participate in internal and external audits, including customer and regulatory audits, as directed by Quality Management.
• Compliance Risk Management: Identify compliance risks, effectively communicate them to senior management, and oversee the implementation of action plans to mitigate risks.
• Cross-Department Collaboration: Collaborate with internal departments to develop strategies and implement quality principles and regulatory requirements.
• Escalate Critical Issues: Promptly escalate critical quality issues to senior management for resolution.
• Stay Current with Industry Trends: Maintain up-to-date knowledge of industry trends, standards, and methodologies related to cGxP and GMP.
• Support Quality System Implementation: Assist in the implementation and maintenance of regulated Quality Systems.

Minimum Qualifications:

• Qualification:
  • Associate's Degree + 4 years of relevant experience
  • Bachelor's + 2 years of relevant experience
• Knowledge:
  • Working knowledge of deviation management and CAPA resolution
  • Familiarity with FDA, EU, and ISO regulatory frameworks (preferred).
• Skills:
  • Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
  • Must be able to organize and prioritize work effectively to meet timelines with quality deliverables
  • Demonstrates proficiency in managing projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines
  • Proficient with Microsoft Word, Excel, Adobe