QA Associate - Systems

Position Description, Functions, Duties and Tasks:

• Oversee specific systems or functional areas as assigned
• Prepare, review, redline, and/or approve GMP documents supporting the site (Procedures, specifications, protocols, reports, change controls, deviations, etc.)
• Implement and maintain systems for complete documentation and control of all required records, logs, and instructions necessary for compliance with cGMP.
• Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long-term resolutions.
• Participate in self led and/or regulatory inspections.
• Educate site personnel on quality matters.
• Function as the back-up for other QA colleagues
• Track and report issues
• Evaluate and execute Change Control, documentation, and drawing requests
• Route-and-release documentation in the Quality System
• Perform training for new and existing team members, prepare training materials as necessary
• Perform Deviation Investigations
• Verify and approve Action plan for Change Control
• Perform walk-through of GMP areas
• Complete assigned CAPAs
• Assist in metric reporting to help drive process improvement for quality systems

• Demonstrated Project Management Skills
• Detailed and Results Oriented
• Solid Computer Skills - Microsoft Office / SAP / SE Suite
• Strong Interpersonal Skills
• Ability to work effectively with respect for others in a team environment
• Excellent communication and organization skills
• adapt readily to change and have the desire to experience new challenges and opportunities.
• this position must provide hands-on support to all plant personnel in a 24/7 work environment and be on call to provide 'over the phone' or 'on site' support and direction
• must be able to travel to all areas of the plant which may include walking, climbing, various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building

• Bachelor of Science Degree (4 year college)

• Demonstrated relevant experience (Quality Assurance, Quality Control, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP.
• Excellent verbal and written communication skills tailored to the appropriate audience.
• Ability to work well at all levels within the organization, comfortable in a manufacturing environment.
• Good interpersonal skills, planning, organization and prioritizing are essential.
• Team building skills, along with the ability to facilitate action plans.
• Must have knowledge of computer systems and software applications, including Microsoft Office applications.

• Competitive Benefits Package and Employee Assistance Program
• 401(k) Plan + Company Match
• Vacation + End of Year Vacation (Company Sponsored)
• Growth Opportunities to expand your career