AbbVie QA Technician I (Temporary - 2nd shift) in Barceloneta, Puerto Rico
QA Technician I (Temporary - 2nd shift)
USA, Puerto Rico, Barceloneta
2 additional locations
USAUSA, Puerto Rico
The primary purpose of this position is to maintain control of the quality of the product and the manufacturing process; in order to ensure a high quality product to our external and internal customers.
The primary functions:
Perform sampling, visual inspections, monitoring of manufacturing processes, verification of the work area, etc., as described by the specifications or by the instructions of the work orders. In this way, it will be determined if a product or raw material (printed or not printed) meets the established quality requirements. Most of the tasks and responsibilities of the Quality Technician I are usually performed under supervision.
Responsible for implementing and maintaining the effectiveness of the quality system.
Execute verification and cleaning of manufacturing lines and filling and packing records using the established specifications. This verification includes that the floor, the tables and the work area are free of all products, documents and materials of previous orders.
Verify that all documentation is in compliance with the regulations of the division, Corporation and FDA.
Verify that all components required by the product specifications are approved and validated.
Be aware of the production specifications to verify the amount of labels to be used in the final product and know how to calculate the expiration date of the product.
Verify that the identification of the lines is present and correct, ensure that the staff is wearing the correct clothing and personal protective equipment.
Receive the file samples ("file samples") of the production personnel and store them in the correct temperature conditions.
Verify the calibration of the equipment and instruments used during the processes and, if necessary, challenge the equipment used to ensure the quality of the product.
Audit the documents used during the manufacturing process to determine if the product meets the established requirements.
Collect, prepare samples and worksheets to be submitted to the "QA" laboratory and microbiology laboratory according to S05 specifications.
Execute process inspections of the products, materials and equipment in the different stages.
Notify quality control supervisors and if necessary place a product on hold (which does not meet the requirements of the specifications). Execute additional tests, as required, in order to determine the disposition of the product.
Review the results of the tests in the LIMS and FLOWSTREAM systems for the preparation of reports. Audit the QC data of the Erweka and LIMS systems. Compile and analyze the results of the QC reports according to the limits of S41 and BOPS to be approved, including the authorization signature to pass the product to the next stage.
Assist quality supervisors in the placement and removal of retention, rejection and quarantine labels.
Execute tests on the equipment (visual, hardness, thickness, weight, disintegration and viscosity) and perform process inspections of the products, materials and equipment in the different stages.
Execute final stage tests (Sealing, torque and inspection of loading platform).
Associate degree, preferably in Natural Sciences
Excellent interpersonal relationship skills.
Verbal and written communication skills in English and Spanish.
Basic knowledge in GMP.
Basic knowledge in mathematics. The minimum requirements are: ability to handle
arithmetic operations (+, -, x, /), and statistical operations (average, minimum, maximum standard deviation, percent and RSD),
Basic knowledge of computers.
Ability to recognize situations that may cause deviations or defects in the product.
Ability to learn quickly and follow instructions, are required.
Effective verbal and written communication skills in English and Spanish.