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Quality Assurance Specialist

JOB OVERVIEW:
The Quality Assurance Specialist (QA Specialist) is a vital position in the operations of Celltex’s laboratory services. The QA Specialist assists in the preparation for, and management of Client/Agency inspections may represent the Quality Assurance department on project teams, ensuring that quality requirements are met. Other duties may include conducting cGMP training for new and current employees, participation in internal audits as required, reviewing cGMP records, document control, CAPA investigations, and overall cGMP compliance. The primary role of the QA Specialist is for final production and quality control record review for the final release of each product.

JOB DUTIES:

• Collaborate with relevant staff to ensure that all components, packaging materials, products, and processes comply with internal specifications and applicable regulatory (FDA) requirements.
• Verify banking eligibility.
• Ensuring the QA department is optimized by streamlining all Quality Operations and Quality Systems.
• Contribute to the design and participation in the implementation of Celltex’s quality management system, including development, improvement, and review of related SOPs, processes, and quality tools as assigned.
• Provide guidance and feedback on quality issues by interpreting and applying GMP and regulatory knowledge in routine and non-routine cases.
• Training and coaching Celltex staff in cGMP and quality principles and in the use of quality tools
• Perform QA reviews of banked, manufactured, and packaged product documentation and samples, including reviews of the batch record to ensure cGMP compliance and completion and accuracy of the appropriate pages.
• Provide guidance & feedback on quality issues. Interpret and apply GMP and regulatory knowledge in routine and non-routine cases.
• Assist in the management of the documentation system, including preparation and issuance of procedures, distribution, and control of copies of official documents, and maintenance of documentation records
• Prepare initial equipment files, assign asset tags
• Conduct periodic reviews of equipment, training, and quality assurance files
• Analyze and work with appropriate personnel on deviations, CAPA investigations, and “out of specifications” final product
• Handle customer complaints in a timely manner. This includes historical trend reviews, investigation, root cause identification, and official documentation of findings
• Successfully able to interpret complex data and draw valid conclusions.

SKILLS/QUALIFICATIONS:

Strong interpersonal, leadership and communication skills. Proficient in the use of spreadsheets, databases, presentation, and word processing software. Exceptional analytical and problem-solving skills. Great attention to detail and precise organization and record-keeping practices. Able to work flexible hours and before/after normal business hours on short notice.

EDUCATION/EXPERIENCE: 

Bachelor’s degree in biological sciences or a related field. Extensive knowledge of FDA requirements and cGMP documentation in regulated biotechnology or pharmaceutical environment.

REPORTS TO: QA Manager

DEPARTMENT: Quality Assurance

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Celltex Therapeutics Corporation is a U.S. Equal Opportunity Employer.