Laboratory Manufacturing Technician - Sacramento, CA

Compensation:  $24 - $28 per hour 

Overview: Nexus HR is looking for a skilled Manufacturing Technician in Sacramento, CA for a biotechnology / in-vitro diagnostics (IVD) company that specializes in medical laboratory testing products for autoimmune diseases.

About the Job

This position performs cell culture and day-to-day manufacturing of all the company’s products. The Laboratory Manufacturing Technician must carry out assignments in accordance with the quality system documentation and in a manner to achieve quality objectives and fulfill the company's product quality requirements. As scheduled, perform quality control inspections and testing of raw materials, bulk reagents, and packaged components following established instructions. This job operates in a manufacturing laboratory setting. This position handles various types of chemicals, acids, bases, and other hazardous raw materials. While performing duties of this job, the employee is required to wear a lab coat and other PPE to ensure personal and/or laboratory safety.

Duties and Responsibilities:

• Initiate action to prevent the occurrence of any non-conformities relating to product, process, or quality system.

• Initiate, recommend, or provide solutions to quality problems through designated channels.

• Identify and record any problems relating to the product, process, and quality system.

• Maintain a clear understanding of the defined authority and responsibilities assigned and the channels to take action.

• Perform all cell culture activities, including the preparation of all cell culture media.

• Manufacture all conjugates and serum-based controls and calibrators.

• Perform all aspects of production and product manufacturing, including slides, reagents, ELISA, and Tissue blocks.

• Project and post cell culture and reagent needs for a given production schedule.

• Participate and/or perform process change activities, including serving as Project Coordinator as assigned.

• Perform quality control inspections and testing of raw materials, bulk reagents, and packaged components following established instructions.

• Evaluate and recommend sera and conjugates for use as raw materials and determine and recommend optimal working dilutions or concentrations of raw materials for use in manufacturing.

• Assist in troubleshooting production problems under the direction of the Production Supervisor or assigned Project Coordinator.

• Maintain quality records in accordance with document control and recordkeeping procedures.

• Assist in updating procedures, work instructions, and forms as required.

• Perform certifications, calibrations, and preventative maintenance on manufacturing equipment.

• Perform housekeeping duties as assigned.

• Assist in the monitoring and enforcement of safe laboratory techniques for laboratory personnel.

• Ensure that documentation and work activities are compliant with the company's Quality System.

• Assist in the enforcement of cGMP to maintain compliance with FDA QSRs, international regulatory requirements, and the established quality system.

• Additional duties, as may be requested by the executive management.

Qualifications:

• Experience in a laboratory or manufacturing environment preferred.

• A four-year degree in Biology or a related scientific discipline is required.

• A clear understanding of immunology, serologic techniques, and diagnostic assays is preferred.

• Specific experience and/or knowledge of general laboratory technique and equipment is required.

• Cell culture, tissue, and/or ELISA methodology experience preferred.

• Corrected vision in the normal range in order to complete forms, input information, and other related tasks is required.

• Must be able to talk and hear effectively to perform job duties.

• Frequently required to stand, walk, and sit for extended periods.

• Must be able to work under a laminar flow hood for extended periods.

• Requires sufficient physical stamina for repetitive manufacturing tasks.

• Must be able to lift and move materials weighing 40 to 60 pounds as needed.

• Requires adequate vision abilities, including: close vision, distance vision, depth perception, and the ability to adjust focus as required for detailed work.

Benefits:

• Dental

• Vision

• Medical

• 401k 

• Paid Leave