Manufacturing Quality Technician

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ImmucorGamma is a global in vitro diagnostics company specializing in the area of pre-transfusion diagnostics. We develop, manufacture, and sell products used by hospital blood banks, clinical laboratories, and blood donor centers to detect and identify certain properties of human blood prior to patient transfusion. ImmucorGamma has revolutionized the industry through our dedication to auto-mating manual processes in the blood bank laboratory.

GENERAL PURPOSE OF JOB



The MQA Technician will ensure compliance of the manufacturing process through auditing, sampling and inspection of the in-process manufacturing areas, as well as ensure compliance of the processing of incoming material and finished goods inspections; segregate non-conforming product/components as necessary.



ESSENTIAL DUTIES AND RESPONSIBILITIES



1. Perform daily QA operations to assure compliance to SOPs and cGMPs.

2. Initiate or assure initiation of product holds and/or deviations per applicable procedures or as directed by Manufacturing Quality Assurance Manager, Supervisor or Lead.

3. Perform inspection of incoming components, in process product and finished product in the manufacturing areas and/or warehouse locations to ensure compliance with established specifications.

4. Perform tests and inspections according to department procedures and complete tasks within procedure or department defined timeframes.

5. Perform duties for the receipt, sampling, issuance and inventory of raw materials, components and product according to departmental procedures as needed.

6. Perform the documentation of procedures designed to assess raw material quality, amount received, used, rejected or returned.

7. Perform product releases to Finished Goods both physically and in the inventory tracking system.

8. Perform daily temperature readings for calibrated temperature areas according to departmental procedures.

9. Follow applicable laboratory OSHA regulations with respect to chemical hazards, blood-borne pathogens, etc and understand FDA and ISO standards applicable to the department.

10. Perform other duties as assigned by the MQA Manager, Supervisor or Lead.

11. Conduct business in a polite, helpful and professional manner with all internal and external customers.


Immucor is an Equal Opportunity Employer and Affirmative Action Employer and a drug free workplace.
REQUIREMENTS
Associate's degree (AA) or equivalent from two-year college or technical school; or six months to one year related experience and/or training; or equivalent combination of education and experience.