Job Description

Quality Control Analyst II

Performs operations necessary for quality testing and plays a role in implementing new technology within quality control. At more senior levels, provides an investigative or technological orientation in designing, executing, interpreting and validating quality procedures and test methods. Completes routine testing of raw materials, in-process and final products in accordance with SOPs for product release and validation. Aids in the development of test methods. Conducts data review and preliminary evaluation of results. Solves problems using limited predetermined options such as repeating the assay when parameters are not met to determine the cause, etc. Provides input to the technical composition of operating documentation. Work is closely supervised. Follows standard practices to obtain solutions. Contributes to the completion of routine technical tasks. Failure to achieve results can normally be overcome without serious effect on schedules and programs. Contacts are primarily with immediate supervisor and other personnel in the section or group. Experience: 3 to 6 years

Skills

• Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties.
• Perform Water, Steam, and Critical Utility collection as well as associated testing.
• Perform Biological Indicator Testing.
• Perform Environmental Monitoring.
• Perform Endotoxin Testing (Gel Clot and Kinetic Turbidimetric).
• Perform Bioburden Testing of In-Process products, buffers, and water.
• Receive manufacturing samples into the QC Lab as well as sample retain disposal.
• Troubleshoot assay and instrument problems with Laboratory Supervisor.
• Enter and review data in LIMS.
• Perform safety and operational lab audit.
• Perform general maintenance of lab equipment.
• Participate in writing and revisions SOPs, protocols.
• Assist in the development and optimization of testing methods.
• Maintain log books related to inventory and equipment.
• Ensure labs are clean and safe (in compliance with cGMP) and properly stocked.
• Make detailed observations in support of Alert, Action, and OOS result investigations.
• Participate in the qualification of equipment, methods, and processes.
• Participate and perform special studies & projects assigned to microbiology
• Perform other additional job related duties as required.
• Perform plate reading, streaking, gram staining, microbial identification.
• Perform routine Quality Control testing of in-process and final products in a cGMP lab for release.
• Practice safe work habits and adhere to Genzyme's safety procedures and guidelines.

Qualifications

• Associates degree in a related discipline and a minimum of 7 years industry experience or Bachelor's degree in Life Sciences discipline and a minimum of 3-6 years experience.

• 3 years experience in a cGMP lab environment
• Working knowledge of Aseptic practices and technique.
• Proficient in Outlook and MS Work and Excel and lab based data management systems

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