Quality Control Sampling & Incoming Inspection Manager

GE HealthCare•Arlington Heights, IL

1d•$95,040 - $142,560•Onsite

About The Position

The QC Sampling & Incoming Inspection Manager oversees all activities related to the sampling and inspection of raw materials, components, and packaging materials in a GMP regulated pharmaceutical manufacturing facility. This role ensures that materials entering the facility are sampled, inspected, and processed according to approved procedures, compendial requirements, and regulatory guidelines (FDA, EMA, ICH, USP/NF, EP). The manager is responsible for supervising samplers and inspectors, ensuring timely material release, maintaining data integrity, and partnering closely with Production, QC Analytical Chemistry, QC Microbiology, QA, and Warehouse Operations. The role involves leading and managing the QC Sampling and Incoming Inspection team, overseeing sampling and inspection operations, ensuring documentation and compliance, leading investigations and quality systems, collaborating cross-functionally, and driving continuous improvement.

Requirements

Associate degree in a scientific or technical discipline with additional relevant GMP experience.
5–8+ years of experience in pharmaceutical or biotech QC, materials testing, or raw material inspection.
2+ years of experience in supervisory or management roles.
Strong working knowledge of GMP (21 CFR 210/211) and ICH guidelines.
Experience with LIMS, material management systems (SAP), and electronic documentation tools.
Understanding of raw material testing and sampling techniques.
Knowledge of controlled environments and contamination control practices.
Strong documentation, investigation, and problem‑solving skills.
Excellent leadership and communication.
Ability to manage priorities in a dynamic, fast‑paced environment.
Strong attention to detail and organizational skills.
Collaborative mindset with cross‑functional teams.
Ability to work in warehouse, sampling booth, and production-adjacent environments.
Be able to meet visual inspection requirements (20/20 near sighted vision).
Lifting of materials/containers up to ~25–40 lbs as required.
Use of PPE: lab coat, gloves, safety glasses, respirators (as applicable).

Nice To Haves

Bachelor’s Degree

Responsibilities

Lead and manage the QC Sampling and Incoming Inspection team, including hiring, training, scheduling, and performance management.
Develop and maintain a culture of GMP compliance, safety, and continuous improvement.
Ensure sufficient staffing and resource planning to meet production and release timelines.
Oversee the sampling of raw materials, APIs, excipients, packaging components, and other regulated supplies.
Ensure compliance with sampling plans, SOPs, and regulatory.
Manage the quarantine, disposition, and flow of materials between warehouse, QC labs, and QA.
Ensure proper control of sampling tools, PPE, labels, and environmental controls.
Review and approve sampling records, inspection reports, and logbooks for accuracy and data integrity.
Ensure ALCOA+ data integrity principles are consistently followed.
Author or review SOPs, forms, sampling plans, and material specifications.
Support regulatory inspections and internal/external audits as the subject matter expert for sampling and incoming inspection.
Lead or support deviations, OOS/OOT investigations, complaints, and root cause analyses related to incoming materials.
Collaborate with QA on CAPA development, effectiveness checks, and continuous improvement initiatives.
Provide material status updates and participate in quality council or review meetings.
Partner with QC Chemistry/Microbiology to prioritize and coordinate sample testing.
Work with Warehouse to ensure proper material handling, identification, and storage under cGMP.
Coordinate effective communication with QA to ensure timely release of materials/chemicals.
Interface with suppliers and Procurement for issues related to material inconsistencies, COAs, and vendor qualification.
Implement improvements to sampling processes, workflow, and documentation.
Evaluate and introduce new sampling technologies, equipment, or process automation.
Trend incoming inspection data and identify opportunities for risk reduction and supply chain robustness.