Job Description

2nd Shift Lab Technician

Monday - Friday - 2nd Shift - 3pm -11pm

Role Description:

Process all incoming raw materials, intermediates, bulk and finished product samples (i.e. purchased materials, production or process technology batches). Perform standard physical and chemical analysis per the approved procedures, ensuring compliance with the written specifications. This position reports to a QC Manager in a cGMP laboratory.

Key Tasks & Responsibilities May include, but not limited to:

• Adhere to all aspects of Corporate and Plant safety programs, GMPs, ISO standards or other regulatory requirements.
• Process all incoming laboratory samples and record the respective batches into the laboratory sample logbook. Composite and manual log-in individual batches as required. Create composite samples for chemical testing.
• Perform or support standard qualitative and quantitative analysis on in-process products, raw materials, packaging components, bulk and finished products in accordance with the approved testing procedures, the National Formulary (NF), and the United States Pharmacopoeia (USP). Perform physical testing on incoming stability samples.
• Assist with non-compliance investigations for in-process work.
• Prepare laboratory reagent solutions and sample grinds for testing needs.
• Adhere to all Bayer and Regulatory guidelines for documentation, ensuring accurate, clear, legible and complete records of all information related to the sample login and release, analytical testing and investigations, preventive maintenance and instrument calibration, inventory and training.
• Document test results into the laboratory notebooks, form sheets and the laboratory information management system (i.e. SAP-QM). Report all non-compliance results to supervisor for further evaluation.
• Review and evaluate others documentation and test results for regulatory compliance and against specifications.
• Perform glassware washing to support the laboratory. Distribute and maintain adequate levels of clean glassware as required for testing needs.
• Monitor the pipette baths and drying desiccators throughout the laboratory.
• Submit work orders for laboratory maintenance as needed. Review and change refrigerators chart recorders.
• Handle the product hazardous waste. Monitor the inventory and use of the recycle and waste drums.
• Participate in laboratory safety audits and solvent dumping schedule.
• Responsible for filing the laboratory documentation and the review of the laboratory documentation prior to filing.
• Update the records for testing procedures and monographs when revised or replaced.
• Assist with the revising of SOPs or testing procedures as needed.
• May perform other duties as assigned, including housekeeping tasks.

Key Working Relationships

• Attend Level 1 team meetings and Level 2 cross-functional meetings.
• Communicate with other departments when testing, documentation, or scheduling issues arise.
• Routine collaboration with the Quality Assurance staff and Manufacturing department personnel.

Qualifications and Competencies

• High school degree or equivalent.
• At least 2 years of relevant post high school education or experience in the sciences. Associate degree in the science is a plus.
• Must be able to fluently read, write, and speak English; ability to understand verbal and written instructions.
• Must have good organizational skills, high degree of accuracy in testing and completing paperwork, and legible handwriting.
• Must have excellent interpersonal skills and have the ability to work effectively in a team environment.
• Previous experience in good manufacturing practices (GMP) and/or government regulated industry preferred.
• Personal computer (PC) skills needed.

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