Quality Operations Lead – GMP & Compliance (DC)

Integrated Commercialization, LLC; Brooks (KY); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, vision

Backup dependent care

Adoption assistance

Job summary

Integrated Commercialization, LLC in Brooks, KY, is seeking a Quality Assurance/Control professional to implement and maintain QA/QC efforts at Cencora Specialty Group distribution centers. You will ensure regulatory compliance, calibration, validation and change control for GMP processes while leading a small team and driving continuous improvement.

The role requires a four-year degree and 4+ years of related experience, strong analytical abilities, and effective communication.

Qualifications

• Requires a four-year degree and 4+ years of related experience.
• Strong analytical and problem-solving skills.
• Ability to communicate effectively, both orally and in writing.
• Knowledge of regulatory compliance matters.
• Experience with GMP processes and quality systems.

Responsibilities

• Support front line operations supervisors in determining root causes using root cause methods.
• Monitor supplier quality issues and coordinate corrective actions.
• Ensure equipment used for GMP processes is compliant with SOPs, calibration, validation and change control.
• Evaluate temperature controlled shipping containers.
• Provide guidance on quality matters such as relabeling.
• Supervise 1–3 associates.
• Develop and analyze reports for quality indicators across DC support functions.
• Maintain relationships with internal customers and regulatory organizations.
• Assist in client audits and gather supporting documents.
• Lead continuous improvement efforts.
• Be on call for temperature excursions or quality emergencies.
• Perform related duties as assigned.

Skills

Analytical skills

Communication skills

Organizational skills

Leadership

Problem solving

Microsoft Office

Warehouse knowledge

Regulatory compliance

Education

Bachelor’s degree

Tools

Warehouse management systems

Microsoft Office Suite

Job description

Integrated Commercialization, LLC in Brooks, KY, is seeking a Quality Assurance/Control professional to implement and maintain QA/QC efforts at Cencora Specialty Group distribution centers. You will ensure regulatory compliance, calibration, validation and change control for GMP processes while leading a small team and driving continuous improvement.

The role requires a four-year degree and 4+ years of related experience, strong analytical abilities, and effective communication.