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Job Description

Job Title: Quality Control Analyst II

Location: Social Circle, GA

About the role:

This position is responsible to ensure that products meet the highest standards of quality and consistency throughout the production process. Quality Control Lead is also responsible for leading a team of analysts, ensuring compliance with local, global, and regulatory standards are maintained. This position will support and drive improvements in safety, customer satisfaction, employee development, and continuous improvement, consistent with plant objectives. Additionally, the Lead Analyst is responsible for leading a team of QC professionals, conducting root cause analysis for defects, collaborating with cross-functional teams, and driving continuous improvement efforts to optimize quality and efficiency within the organization.

How you will contribute:

• Ensure the safety of all team members by promoting and enforcing safety protocols in the lab and work areas.

• Act as a coach and mentor, providing guidance and support for employee growth and development.

• Lead team meetings, fostering open communication and collaboration.

• Oversee and guide the team in day-to-day activities, ensuring smooth laboratory operations by assigning tasks, monitoring performance, and providing guidance and training to ensure high standards are maintained.

• Take ownership of area sampling, testing, and all laboratory processes.

• Ensure compliance with cGMP regulations by all team members, conducting routine Gemba walks to verify adherence.

• Manage departmental needs, ensuring that all testing and data are released within the required time frames (i.e. attend daily tier 1, tier 2, or other meetings)

• Perform routine, and non-routine testing as required

• Maintain testing qualification, and ensure adherence to standards

• Ensure the accuracy of operational SOPs; redline SOPs and related documents when updates are required.

• Prepare management updates, including metrics, in a timely manner.

• Actively participate in audits and audit preparation.

• Lead laboratory tours for internal and external visitors.

• Identify and drive the completion of remediation activities and continuous improvement initiatives. 

• Attend and participate in Quality forums and contribute to investigational teams as needed.

• Own and manage special projects as defined by the Quality Control Leadership Team (QCLT).

• Support owning, approving, and/or reviewing investigations, CAPAs, and/or Change Controls within the required time frames.

• Adhere to standard work requirements within the laboratory

• Author, review, and/or approve SOPs, job aids as needed

• Proactively escalate issues to the department manager/ supervisor as soon as they are identified, ensuring quick resolution and preventing delays in operations.

Complexity and Problem Solving

• Ability to support team through scheduling, coaching, and influential leadership

• Work with cross-functional team to identify improvement initiatives, and implement identified initiatives

• Troubleshooting, and/or problem solving and root cause analysis to ensure sustainable solutions.

Internal and External Contacts

• Supervisors, Managers, Associate Director, and other departmental leadership

• Compliance Team

What you bring to Takeda:

• Requires bachelor's