QC Analyst I

Boca Raton, FL - USA

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: QC Analyst I

Location: Boca Raton FL

Duration: 6 Months

Job Description

Performs laboratory tests including routine and specialized testing for contracts and customers in compliance with GMP and established procedures.
Perform instrument calibration or qualification according to written procedures.
Perform instrument troubleshooting including performing minor repairs of equipment/instruments and contacting supplier when necessary following all normal procedures.
Manages reagent inventory and supply inventory as assigned. Provides support and oversight maintaining cleanliness and organization of storage areas.
Able to prepare reagents with ability to utilize the equipment for such preparation.
Maintain thorough and up-to-date knowledge of all related Standard Operating Procedures (SOPs) for the lab.
Oversee pooling operation. Ensure bleeds are pulled pipetted and tested in a timely manner.
Run specialized computer programs for designated assignments: Excel e-mail word access LIMs SAP EDMS.
Must be flexible change ready and available when necessary to support Laboratory operations.
Assist laboratory Supervisor and other staff as required and Perform additional tasks or take part in special projects as assigned by management.
Accountable for following Standard Operating Procedures (SOPs) and adhering to cGMP guidelines.
Utilize cGMP practices in documentation and execution of job functions.
May be trained and assigned to provide oversight for RBC area and monitor the inventory of frozen red blood cells and monitor the whole blood units as they are available for freezing
Review documentation on trained tasks assigned by Supervisor or designee.

Education Requirements: Associate or BS with some lab experience

Experience Requirements:

This position requires 0-3 years of experience in a laboratory setting. Working experience in a FDA regulated environment preferred but not required. Other

Essential Knowledge:

Familiarity with chemical biochemical and/or microbiological testing is desired. Good communication skills detailed-oriented and able to work well with others are necessary qualities. The individual should be flexible and be able to handle multiple priorities. Able to use personal computer for data entry. Perform math calculations involving dilutions fractions decimals and percentages. Understand and follow instructions record information find solutions to practical problems or request assistance.

Contacts: Internal: Frequent contact with Manufacturing Facilities QA and Receiving personnel. Frequent contact with management. External: Contact with technical service representatives and vendors may be required. Decision Making: Exercises judgment within defined procedures to determine appropriate action to routine problems. Prioritization of work with direction of Laboratory Management.

Conditions: Exposure to infectious material (human source products) toxic chemicals chemical fumes and odors electrical hazards temperature extremes when going to and from coolers and freezers.

Physical Demands: Sits at desk or bench 15 20% of the time and operates a personal computer using sign and finger dexterity. Sits at laboratory bench 70-75% of the time testing samples. 10% of the time lifting carrying pushing pulling chemicals samples and supplies weighing no more than 20 lbs. Stressors: Shift work and long or unusual work hours are required.

Job Title: QC Analyst I Location: Boca Raton FL Duration: 6 Months Job Description Performs laboratory tests including routine and specialized testing for contracts and customers in compliance with GMP and established procedures. Perform instrument calibration or qualification according to writt...