At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!

SUMMARY:

Quality Assurance (QA) Specialist 1 will be responsible for providing QA Support for the Manufacturing and Production Departments via line clearance inspections and release of room and equipment for use. QA Specialist 1 will monitor and verify that GMPs and SOP processes are being followed in Operations.

QUALIFICATIONS AND REQUIREMENTS:

• High school diploma required. Associate or bachelor’s degree in science related field preferred.
• Experience in related pharmaceutical or other manufacturing industry and/or QA functions required. Must demonstrate quality-mindedness and the ability to adapt to changing priorities.
• Pharmaceutical experience in a cGMP environment preferred. Basic knowledge of GMP and FDA regulations is preferred.
• Proficient in Microsoft Office Suite, including Word, Excel, and Outlook.
• Proficient in Quality Management Systems and ERPs, such as Master Control, Microsoft Dynamics 365, or other electronic document control systems.
  PBI-Gordon Companies and its subsidiaries are proud to offer a comprehensive benefits package to eligible, full-time employees who work 30 hours per week or more. Full-time employees will become eligible to participate in benefits on the first of the month following their start date, unless stated otherwise below. (Note: Interns do not qualify for eligibility.)

• Answer calls from Operations for room signoffs, start-ups, clearances, cleaning verifications, balance calibration and other needs
• Daily inspections of production areas and perform in-process checks to ensure cGMP compliance.
• Maintain the label room areas per compliance and facility cleaning requirements
• Count, issue, print, reconcile and perform inventory adjustments for critical packaging components utilizing the ERP system
• Utilize Master Control to perform training and sign offs as needed
• Maintain Reserve Sample program for finished Products
• Assist with critical packaging component investigations as required
• All other tasks as requested or assigned.