Quality Assurance Specialist

Quality Assurance Specialist

Trillium Professional is now seeking a Quality Assurance Specialist – Cell Therapy & Quality Systems Validation in Boston, MA for a direct-hire opportunity!

This is an on-site position and the annual salary is $98,500–$109,100.

We are seeking a Quality Assurance Specialist with experience supporting regulated cell therapy, cell processing, or laboratory environments. This position combines hands-on quality assurance and regulatory compliance responsibilities with a strong focus on information systems, databases, computerized quality systems, and validation.

The ideal candidate will have experience working within cGMP/cGTP environments and a strong understanding of quality systems, auditing, regulatory requirements, deviations/CAPA, and computerized systems used within a regulated laboratory or manufacturing setting.

Key Responsibilities

• Support quality assurance and continuous improvement activities within a regulated cell therapy and laboratory environment.
• Perform internal audits and assessments to ensure compliance with applicable regulatory and accreditation requirements.
• Support compliance with FACT, FDA, JCAHO, AABB, CLIA, DPH, OSHA and other applicable standards.
• Prepare for and participate in regulatory inspections, compliance audits and sponsor audits.
• Support quality programs associated with hematopoietic progenitor cells, therapeutic cells and other cell-processing activities.
• Assist with regulatory activities including IND submissions, FDA registration and licensure.
• Lead and facilitate quality processes including RCA, CAPA, FMEA, deviation management and continuous improvement initiatives.
• Track and analyze deviations, OOS events, errors and adverse events and identify opportunities for quality improvement.
• Review manufacturing, quality control and clinical trial batch records for compliance and initiate corrective actions when needed.
• Support development, implementation and monitoring of laboratory databases, information systems and computerized quality systems.
• Participate in validation of new systems, instruments, methods and related technologies.
• Recommend and perform audits to assess database and information-system performance.
• Maintain accurate electronic and manual quality records and support data integrity.
• Extract, analyze and trend data using databases and spreadsheets.
• Develop and maintain quality policies, procedures, laboratory manuals and training materials.
• Provide GMP/GTP, quality systems and compliance training to laboratory personnel.
• Serve as an independent auditor and verifier for assigned clinical trial procedures and processes.
• Support product testing, release activities and continuous quality improvement initiatives.

Qualifications -Experience in quality assurance, quality systems, compliance or validation within a regulated laboratory, biotechnology, pharmaceutical, cell therapy or related environment. Working knowledge of cell processing principles and practices. Experience with auditing and regulatory compliance. Knowledge of cGMP and cGTP requirements. Familiarity with applicable regulatory and accreditation requirements, including FDA, FACT, AABB, CLIA and JCAHO. Experience with deviations, CAPA, RCA, FMEA, OOS investigations and quality improvement processes. Experience supporting computerized systems, laboratory databases, information systems or quality systems within a regulated environment. Experience with system, instrument or method validation. Strong database and spreadsheet skills with the ability to extract, analyze and trend data. Strong documentation, analytical, problem-solving and organizational skills. Excellent interpersonal and communication skills with the ability to work effectively across laboratory, quality, technical and clinical teams. Experience troubleshooting laboratory instrumentation and assay systems is desirable. General laboratory, aseptic technique, laboratory safety and infection-control knowledge preferred.

This is an excellent opportunity for a quality professional who understands both the regulated laboratory environment and the information systems that support quality, compliance and cell therapy operations.

Trillium has been recruiting and placing clerical and office professionals for over 30 years. From Fortune 100 companies to small businesses, our philosophy remains the same: to achieve excellence by providing quality employees with an uncompromising level of service. We believe in honesty, integrity, and a simple philosophy of providing value to our customers and our employees. We strive to be unsurpassed in the recruitment and placement of professionals. Trillium is an Equal Opportunity Employer.

Trillium offers a comprehensive benefit package that includes the ability to participate in health insurance and retirement plans, paid holidays, state required leave, and other leave, if applicable. Trillium's offerings are dependent on the state in which the assignment is located, length of time worked, and may change depending on assignment. Benefit packages for direct hire placements vary based on the client company.