Job Description

Quality Specialist

About the Role

Our client, a global organization with a strong focus on quality, is seeking a dedicated Quality Specialist to join their team in Columbus, Georgia . This is an onsite position crucial for managing quality processes, addressing customer complaints, and driving continuous improvement. You'll work closely with cross-functional teams to ensure adherence to the Global Quality Management System and maintain a state of compliance. This role offers excellent opportunities for professional growth and involvement in key business processes.

Key Responsibilities

• Process Management & Compliance:
• Manage and execute quality processes, ensuring end-to-end adherence to the Global Quality Management System (QMS) .
• Coordinate the workflow of complaints, ensuring they are accurately documented and managed within the EQMS system .
• Monitor and support the implementation of Product Notification Initiatives (PNI) very early in the product lifecycle.
• Ensure all written communications, including customer responses and technical documentation, are drafted in a compliant manner .
• Participate in management reviews and track Key Performance Indicators (KPIs) .
• Corrective and Preventive Action (CAPA):
• Investigate and analyse issues to determine the root cause of customer complaints and process deviations.
• Develop, write, and implement effective Corrective Actions and Preventive Actions (CAPA) .
• Work collaboratively with various departments to ensure timely and effective completion of CAPA tasks.
• Quality Operations:
• Oversee validation work for manufacturing sites.
• Conduct or support inspections of incoming material.
• Assist in preparing for and conducting Quality Audits and supplier visits .
• Customer & Stakeholder Interaction:
• Provide clear, professional, and timely customer responses .
• Serve as a key interface, working closely with teams to understand the root cause of customer issues.
• Manage regulatory impact and project timelines (reg impact Timeline management).

Qualifications & Experience

Required:

• Experience: Ideally 4+ years of professional experience in a regulated industry, with specific experience in corrective and action processes .
• Technical Background: Demonstrated technical background, particularly in understanding regulatory impacts.
• Location: Ability and expectation to work onsite in Columbus, Georgia .
• Industry Experience: Prior experience in the healthcare or other highly regulated. industries (e.g., consumer sector, chemical, cosmetic, or food industry) is ideal.
• Strong understanding of FDA regulations .
• System Knowledge: Familiarity with EQMS systems is beneficial.

Work Environment & Benefits

• Location: Onsite role based in Columbus, Georgia , where sites are currently expanding, offering significant opportunity for professional growth.
• Flexibility: The role offers some flexibility with remote work (WFH) , However, the preference is for the ideal candidate to be on site 5 days per week.
• Growth: Excellent opportunity for a candidate who is eager to grow their career, with a lot of involvement in management reviews and KPIs.
• Team: You will be joining an established Quality team that includes other specialists.

Application

If you are a driven quality professional with a passion for compliance and process improvement, and you are ready to take on a challenging role in a global organisation, we encourage you to apply!

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