Quality Control Analyst (2nd shift)

Position

The primary role of this position is to provide operational support for the Quality Control (QC) cGMP functions for laboratory, radiologic science laboratory, and manufacturing operations. Role will focus on support activities, such as sampling, material inspection, and general laboratory testing/support. Projects and duties will be completed in compliance with applicable regulatory agency standards.

Responsibilities

• Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
• Operate analytical instrumentation.
• Provide on-the-floor QC presence for manufacturing operations.
• Perform incoming inspection of raw materials and components.
• Review and approve Receiving Inspection documents and release in the ERP system.
• Perform environmental monitoring tasks and plate reads.
• Isolate microorganisms.
• Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs.
• Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys.
• Maintain QC and Micro lab which includes routine housekeeping, review of logbooks and inventory maintenance.
• Train others on methods, procedures and techniques as required.
• Participate in Project Teams and other meetings.

Qualifications

High school diploma or general education degree (GED) and minimum four (4) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience); OR Bachelor's Degree in chemistry, biology, or other related scientific discipline; OR equivalent combination of education and experience.

Preferred Qualifications

• Familiarity with use of basic to advanced metrological equipment.
• Knowledge of ALARA principles, operating radiation detection equipment, and handling of radioactive materials.
• Benchtop chemistry, titration, chemical ID testing.

Shift Information

Second shift hours are Tuesday, Wednesday, Thursday, Friday 1:30pm – midnight (off on Mondays). During this position's training period (approximately 60 days), the ability to work an alternate shift at least once during the training period is required. Primary shift placement will occur upon completion of the training program. Additionally, this position supports production in a 24-hour manufacturing facility, Monday to Friday, occasional overtime and holidays required.

Working Conditions

Physical demands may include, but not be limited to, specific vision abilities including near vision/acuity and visual color discrimination. This role may involve working in a controlled cleanroom environment, general office setting, or specific manufacturing areas. Conditions may include exposure to varying temperatures, noise levels ranging from quiet to loud, and specific vision abilities. Personal Protective Equipment (PPE) is required and may include respirators, gloves, safety glasses, and full protective clothing. Compliance with cleanroom gowning protocols is required. As a radiopharmaceutical manufacturing site, radiation may be present in the laboratory and production areas. Employees in this role may be required to follow strict radiation safety procedures, participate in dosimetry monitoring and bioassay testing, and inform leadership of any health conditions that may affect product integrity.