Quality Supervisor

Premier Staffing Solution•Greenfield, IN

19d•Onsite

About The Position

The Quality Supervisor leads daily quality operations in the Raw Material Warehouse and Sampling Suite, ensuring compliance with GMP, regulatory agency, and client-specific requirements. The role oversees Quality Associates responsible for receiving, inspecting, sampling, and testing raw materials and components, while maintaining controlled cleanroom and sampling conditions to protect product integrity and prevent cross-contamination. The supervisor manages team performance and workforce planning and serves as a liaison among Quality, Warehouse, and Operations to resolve material quality issues, deviations, and client inquiries. The role supports audits, continuous improvement initiatives, and cross-functional projects, and ensures compliance with safety, security, and regulatory requirements, including hazardous-material handling and applicable DHS and FDA requirements. The position plans and allocates daily manpower, schedules, and work instructions; assigns tasks according to team members’ skills; ensures sampling and inspection are accurate, timely, and GMP-compliant; and maintains inspection readiness. It also oversees quality systems, reviews quality records, supports employee development and cross-training, and leads initiatives to strengthen operational efficiency and regulatory compliance.

Requirements

Bachelor’s degree in a scientific or technical discipline, such as Biology, Chemistry, or Pharmaceutical Sciences, or equivalent experience.
Minimum 3 years of Quality experience in a GMP-regulated environment.
Strong knowledge of GMP regulations, including FDA, EU, and ICH requirements.
Previous supervisory or managerial experience is required.
Strong understanding of current Good Manufacturing, Good Distribution, and Good Documentation Practices (GMP/GDP) as applied to raw materials and pharmaceutical distribution operations.
Proficient computer skills, including Microsoft Office.
Planning and organizational skills to manage a dynamic environment with shifting priorities.
Ability to assess situations, evaluate risks, and implement effective, compliant solutions in a GMP environment.
Effective verbal and written communication with internal and external teams.
Ability to analyze information and data to assess potential product-quality risks.
Ability to build professional relationships and rapport with internal and external peers and management.
Ability to anticipate product and operational problems and risks and investigate solutions.
Ability to manage multiple quality records with varying due dates, ensure timely completion, and maintain records in a readily retrievable format.
Ability to bend, stoop, and lift up to 50 pounds as part of the daily work routine.

Responsibilities

Lead, mentor, and develop Quality Associates working in the Raw Material Sample Suite.
Promote a culture of compliance, accountability, and continuous improvement.
Ensure sampling, inspection, and testing activities comply with GMP, FDA, and client requirements.
Oversee cleanroom operations, including gowning, trafficking, cleaning, environmental monitoring, and contamination control.
Manage and support quality system processes, including deviations, CAPA, change control, investigations, and training related to the Sample Suite.
Review and approve quality records for completeness, accuracy, and regulatory compliance.
Oversee quality checks for incoming raw materials and sampling processes to ensure product integrity and traceability.
Collaborate with Warehouse and Operations to resolve material discrepancies and quality-related issues.
Serve as the primary quality contact for internal and external audits and inspections related to the Sample Suite.
Communicate with clients about quality issues in a timely and accurate manner, consistent with SOPs and Quality Agreements.
Identify process gaps and lead initiatives to improve operational efficiency and regulatory compliance.
Conduct risk assessments to support decisions and quality oversight.
Ensure compliance with safety protocols and hazardous-material handling guidelines, as well as applicable DHS, FDA, and other regulatory security requirements.
Work according to company values, policies, and procedures and deliver quality objectives in partnership with management through resource management, prioritization, schedules, and projects.
Plan and allocate daily manpower, schedules, and instructions to complete sampling, inspection, and quality control activities on time and in line with client and operational priorities.
Assign daily tasks based on team members’ skills, including gowning, sampling, environmental monitoring, inspection, documentation, and material checks.
Accept or reject raw materials based on quality, regulatory, and client-specific standards.
Physically verify incoming and outgoing raw materials for damage, discrepancies, and compliance with specifications.
Cross-train Quality Associates to support operational flexibility and coverage across suite functions.
Use systems and tools effectively, including LIMS, Raman, calipers, and Go / No Go gauges, where applicable.
Ensure team activities comply with policies, SOPs, GMP requirements, and safety standards.
Coach and support employees, helping them address work-process challenges and reinforcing compliance expectations.
Maintain inspection readiness and provide oversight and maintenance of quality systems.