QC Analyst

GENERAL PURPOSE

Perform quality control testing of raw materials, in-process and final products; following general instructions on routine work and detailed instructions on new assignments.

Performs laboratory tests including routine and specialized testing for contracts and customers in compliance with GMP and established procedures.

• Perform instument 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 staffs 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.

Nature of Work and Scope

Education Requirements: B.S. in Chemistry, Biochemisty, Molecular Biology or related science discipline for Chemistry Lab. B.S. in Biological Science or related science discipline for Microbiology Lab.

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, chemcical fumes and odors, electrical hazards, temperature extemes 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.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties, and skills required.

We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

EEO Minorities/Women/Disabled/Veterans

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Location: NORTH AMERICA : USA : FL-Boca Raton:USBOCLA - RPSTO

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