Quality Control Sampling & Incoming Inspection Manager

Job Description Summary

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.

Job Description

Key Responsibilities

Leadership & Oversight

• 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.

Sampling & Inspection Operations

• 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.

Documentation & Compliance

• 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.

Investigations & Quality Systems

• 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.

Cross‑Functional Collaboration

• 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.

Continuous Improvement

• 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.

Qualifications

Education

• Bachelor’s Degree is preferred
• Associate degree in a scientific or technical discipline with additional relevant GMP experience.

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.

Technical Skills

• Understanding of raw material testing and sampling techniques.
• Knowledge of controlled environments and contamination control practices.
• Strong documentation, investigation, and problem‑solving skills.

Behavioral Competencies

• 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.

Physical & Environmental Requirements

• Ability to work in warehouse, sampling booth, and production‑adjacent environments
• Work will include infrequent activities within a radioactive environment. No direct work with radioactive material will be required.
• 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).

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $95,040.00-$142,560.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.