QC Analyst I

Job Title : QC Analyst I
Location:  Boca Raton, FL
Hourly Pay Rate : $25.00 per hour on Contract W2
Schedule:8:00AM to 4:30 PM
 

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 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 (SOP’s) 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 as 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.

Working 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.
Background: Address to Criminal History (7 year) Address to Federal Criminal
History (7 year) AKA Names Provided (up to 9) Education Verification
Employment Verification (up to 1 years or last employer) Office of Inspector
General Sanctions (OIG) Social Security Address/Alias Trace System for Award
Mgmt (SAM) Exclusion USA CriminalSearch USA OffenderSearch USA
SecuritySearch 9 panel (NO THC Test)