Quality Control Analyst II

Lonza - Walkersville, MD

Full-time - Mid Level

Walkersville, MD

Professional, Scientific, and Technical Services

About the position

The Quality Control (QC) Analyst II at Lonza is a mid-level position that plays a crucial role in ensuring the quality and compliance of products through rigorous testing and monitoring. This role involves performing routine Environmental Monitoring (EM) and utility sampling, as well as conducting specialized testing of raw materials, in-process materials, finished goods, and stability samples. All activities must adhere to Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOPs). The QC Analyst II is responsible for executing routine testing and project-related tasks while also providing general lab support as directed by management. In this position, the analyst will perform testing and enumeration according to established procedures for various materials, including raw materials, packaging components, in-process products, finished products, and stability samples. The role also includes supporting Aseptic Process Simulations (APS), method validations, method transfers, and process and cleaning validations as required. The QC Analyst II will review, analyze, interpret, and report data in a timely manner, following Good Documentation Practices (GDP) and ALCOA+ principles. Additionally, the analyst will prepare sample shipments and submission paperwork for contract laboratory testing, maintaining communication with the contract laboratory as necessary. Responsibilities also include authoring, reviewing, and revising SOPs, trend reports, and microorganism assessments. The QC Analyst II will assist in developing training plans and curricula, training other analysts as needed, and leading investigations into Out of Specification (OOS) results and deviations, implementing Corrective and Preventive Action (CAPA) plans with oversight. General lab support activities such as housekeeping, equipment maintenance, and inventory management are also part of the role. The analyst will develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory equipment and software, and participate in method validation commensurate with their experience. Other duties may be assigned as necessary.

Responsibilities

• Perform testing and enumeration in accordance with written procedures for raw materials, packaging components, in-process products, finished products, and stability samples as needed.
• Conduct testing to support Aseptic Process Simulations (APS), method validations, method transfers, process, and cleaning validations as needed.
• Review, analyze, interpret, and report data following GDP and ALCOA+ principles in a timely manner.
• Prepare sample shipments and submission paperwork for contract laboratory testing and communicate with contract laboratory as needed.
• Author, review, and revise SOPs, trend reports, and microorganism assessments as needed.
• Assist in the development of training plans and curricula; train other analysts as needed.
• Lead OOS/deviations/investigations and implement CAPA plans with oversight as needed.
• Perform general lab support activities such as housekeeping, equipment maintenance, and inventory/ordering of supplies.
• Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory equipment and software.
• Participate in validation of methods, commensurate with experience.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree in a life sciences field
• 5+ years' experience in Quality CGMP experience required