Job Description Summary

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.

CrossFunctional 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

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

Experience

• 58 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 problemsolving skills.

Behavioral Competencies

• Excellent leadership and communication.
• Ability to manage priorities in a dynamic fastpaced environment.
• Strong attention to detail and organizational skills.
• Collaborative mindset with crossfunctional teams.

Physical & Environmental Requirements

• Ability to work in warehouse sampling booth and productionadjacent 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 2540 lbs as required.
• Use of PPE: lab coat gloves safety glasses respirators (as applicable).

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.