QUALITY ASSURANCE ASSOCIATE 1 or 2

Position: Quality Assurance Associate I/II

We are seeking a self-motivated team player with attention to detail, who enjoys organizing, making processes better, and making a difference in patient lives. The successful candidate will serve an essential role in supporting clinical product launch and production. This includes batch record review, deviation investigation, label issuance, and word processing, tracking, issuing, distributing, and archiving companywide GLP/GCP/GMP controlled documentation, training, and facility support systems.

Responsibilities:

• Support clinical product manufacturing by batch record review, label printing, product packaging, and shipping
• 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
• Coordinate / track / 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 and material management, including ordering, incoming receipt, record keeping etc.
• Inventory database management including accurate and timely updating of lot numbers and quantities
• Collaborate on development / improvement and implementation of material, facility and quality management systems
• Other required duties as may be assigned

Requirements:

• Bachelor’s Degree and 2+ years of experience in a cGMP environment
• Knowledge of standard processes involved in document control and experience in an FDA regulated environment
• Experience in Aseptic Processing a plus
• Precise attention to detail
• Excellent record keeping skills
• Strong, demonstrable computer skills in MS Word, Excel, Visio, Access; Adobe suite; and database systems
• Familiar with Quality Systems and records management in a cGMP environment.
• Strong communication and problem-solving skills
• Results oriented with dedication to compliance and customer service
• Strong initiative and follow-through
• Comfortable working in a fast paced and dynamic environment.

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