Quality Control Specialist

Quality Control Specialist

Growing Radiopharmaceutical Contract Manufacturing (CMO) site has a new direct hire opportunity for a Quality Control Specialist to join their team! The CMO site manufactures and provides radiopharmaceuticals, medical isotopes, and related services, particularly for cancer treatment and research. They offer a very generous compensation & benefits package as well as a very pleasant work culture!

Job Summary: The Quality Control Specialist will assist the Quality Control Manager in maintaining an effective quality control program which consistently strives to test and release high quality products on time. This person will participate in quality tests and inspections to verify that appropriate current procedures are followed and will keep the QC Manager fully informed on the status of QC activities.

Responsibilities:

• Operates under the guidance of the QC Manager to assure compliance with the company’s quality control program as well as the quality management system (QMS)
• Communicates with the QC Manager on activities related to quality control
• Performs final quality control testing on products as assigned by the QC Manager
• Performs periodic calibration and qualification of analytical equipment, which include:

Pipettes

Analytical balances

Incubators and ovens

Freezers and refrigerators

Gamma and alpha spectrometers

Liquid scintillation counters

HPLC Systems

• Assists in analytical methods development and validation activities
• Performs incoming materials inspection and carries out quantitative and qualitative tests to qualify them as per approved protocols
• Maintains inventory and usage log for raw materials
• Assists in deviations, root cause analyses, corrective/preventive actions and non-conformity reports
• Carries out filing, organizing and record keeping of QC documentation
• Recommends continual improvement changes to QC procedures and processes where necessary.
• Performs other duties as assigned by QC manager

Requirements:

• Bachelor of Science (B.S.) degree in relevant discipline (Chemistry, Pharmacy, Nuclear Chemistry, Biochemistry etc.)
• Minimum 2 - 3 years’ experience with pharmaceutical Quality Control, preferably radiopharmaceutical.
• Proficient in the operation, calibration and routine maintenance of general analytical equipment, such as balances, pipettes, HPLC systems etc.
• Proficient in the review, revision and authoring of official documents such as standard operating procedures, work instructions etc.
• Proficient in Microsoft Excel and Word
• Able to lift up to 50 lbs.

Desirable Traits:

• Experience of working with measuring equipment pertaining to radioactivity (gamma spectrometers, alpha spectrometers, liquid scintillation analyzers, gamma counters, dose calibrators etc.) is highly desirable
• Experience of working with HPLC, GC, ICP/OES is highly desirable
• Experience working with electronic document management systems / LIMS
• Experience in statistical analysis and trending of QC-relevant data
• Knowledge of the conceptual and practical application of cGMP in a pharmaceutical environment
• Able to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
• Hands-on, having a knack of working with tools and fixing minor equipment maintenance issues
• Detail-oriented and organized with excellent written and verbal skills
• Able to work independently as well as in a team
• Is flexible to work odd hours and occasionally on weekends/holidays, as needed.