Job Details

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!