Position: Quality Assurance Associate III

We are seeking a self-motivated team player who is meticulous and has a keen eye for detail. The successful candidate should have a knack for organization, a drive for improving processes, and a desire to make a difference in patient lives. The selected candidate will serve an essential role in supporting clinical product launch and production. Responsibilities include batch record review, deviation investigation, label issuance, and tracking, issuing, distributing, and archiving companywide GLP / GCP / GMP controlled documentation, training, and facility support systems.

Knowledge of standard processes involved in document control and experience in an FDA regulated environment is required. The position will report to the Sr. Manager of Quality.

Responsibilities:

• Support clinical product manufacturing by conducting batch record review/disposition, label printing, product packaging, and shipping
• Working knowledge of 21 CFR 210 and 211, ICH, ISO9001, EU Guidelines and other relevant FDA regulations is a must
• Conduct or coordinate deviation investigations, corrective and preventative actions (CAPA), change controls, company-wide training, and internal audits. Write associated reports
• Process controlled documentation through the GxP (GLP / GCP / GMP) documentation system, including but not limited to word processing, tracking, issuing, distributing, and archiving, utilizing manual or an electronic document management system
• Collaborate on the development, improvement, and implementation training program, and other quality management systems, as assigned
• Coordinate, track, and archive controlled records (i.e., batch/test records, logbooks, validation documents, labels, reports, forms, etc.) for change controls, deviations, CAPAs, audits, training, equipment calibration, and preventative maintenance
• Write and/or review policies, standards, procedures, and work instructions to document Quality documentation processes and practices
• Support supplier management program
• Inventory database management, including accurate and timely updating of lot numbers and quantities
• Support regulatory/submission activities
• Ability to participate and prepare relevant materials for Management Review and Material Review Board meetings
• Perform other required duties as may be assigned.

Requirements:

• Bachelor’s Degree and 3-5 years of experience in a cGMP environment
• Experience in commercial cell therapy company is highly desired
• Experience in Aseptic Processing is a plus
• Attention to detail and excellent record-keeping skills
• Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
• Good oral and strong written communication skills
• Familiarity with Quality Systems and records management in a cGMP environment
• Strong problem-solving skills and the ability to coordinate and perform multiple activities
• Results-oriented with dedication to compliance and customer service
• Strong initiative, independence and follow-through
• Comfortable working in a fast-paced, cross functional team and dynamic environment
• Comfortable dealing with rapidly changing priorities

Work Environment / Physical Demands:

• Must be able to sit and stand for extended periods
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork