QA Operations Associate

Job Description

The QA Operations is responsible for supporting our client’s quality operations including managing and storing of cGMP documentation and records issuance. The QA Operations will Interact with different levels of management and personnel within each department.

Responsibilities:

• Responsible for the company’s Quality Operational Support including managing and storing of cGMP documentation, records issuance, and provide support in QA oversight of manufacturing activities as needed
• Manage documentation program lifecycle from issuance of documents to archival. Provide oversight of inventory tracking system for archived cGMP documentation
• System Administration of Master Control
• Prepare and review documentation for release of finished product. Provide support in final release of finished product
• Partner with manufacturing to provide QA oversight of operations and to solve in any quality concerns during the manufacturing of product
• Write, review, and approve SOPs and Forms for manufacturing processes.
• Report quality issues to management
• Educate manufacturing team on quality control issues and work with departmental managers to improve overall company product quality
• Conduct/assist investigation process for quality event; participating in triage events, identifying root cause and corrective and preventive action
• As the workload demand changes for the department, additional responsibilities may be required

Qualifications:

• High School Diploma required; Bachelor’s Degree in a Science related field preferred
• Experience with Current Good Manufacturing Processes (cGMP) regulations
• Ability to translate skill and knowledge to others and to interpret regulations
• Basic understanding of manufacturing in cGMP environment, documentation and data integrity requirements
• Highly strategic as well as hands on, detail-oriented and metric driven
• Ability to manage multiple projects/tasks simultaneously
• Experience managing systems, including problem-solving skills
• Strong attention to detail, time management, and organizational skills
• Advanced computer skills, including Outlook, Excel, Word, PowerPoint and quality systems (MasterControl)
• Strong verbal and written communication skills, including the ability to organize information and present it to peers and members of Senior Management

Work Environment and Job Demands:

• Various facilities within and outside of the company
• Office, laboratory, processing floor, warehouse and other, as necessary
• May be asked to occasionally work in hot and cold environments, as necessary
• Must be able to remain in a stationary position and/or move throughout the facilities for extended periods of time, as necessary
• Must be willing to work weekends, as necessary
• Must be able to work independently, as necessary