Quality Technician I (2nd Shift)

Johnson & Johnson Innovative Medicine•Añasco, PR

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. We are searching for the best talent for Quality Technician I (2nd Shift). Purpose: Performs Incoming Inspection and/or Product Release roles per established procedures. Incoming Inspection: Performs inspection of raw materials, in-process product and/or finished goods and ensures conformance with established standards. Follows standard operating procedures (SOP’s) under good manufacturing and Laboratory practices (GMPs, GLP’s). Product Release: Responsible for auditing all batch records for completeness and correctness and filing of records. Maintains lot history records, fills logbook data, and generates NCRs, certificates, and reports if required.

Requirements

A minimum of High School diploma or equivalent (General Education Development, GED) is required.
Minimum of two (2) years of experience in a Medical Devices or Pharmaceuticals environment, preferably in Quality.
Availability of working rotating shifts and flexibility on scheduled is required.

Nice To Haves

Associate’s degree is preferred.
Experience in material/product inspection or documentation preferred.
Computer literate knowledge in Microsoft Excel and Word programs preferred.

Responsibilities

Performs statistical sampling of raw materials, in process product and/or finished goods received as per the sampling plan specified in the corresponding inspection/testing document.
Performs varied product inspections, generally of components, incoming materials, new products or finished goods, by observing, measuring and recording data as required in the corresponding inspection/testing document. Inspection performed may include visual inspection, proof reading, and measurements.
Compares inspection results to defined requirements or specifications and documents differences found.
Records results of inspection in inspection/testing document filling out all applicable entries as per the established GDP and GMP requirements.
Compiles and inputs data, documents findings and interprets results.
Compiles and maintains quality requirements documentation.
Notifies Supervisor, Quality Engineer and/or proper department about non-conformances found during sampling and/or inspection of raw material, in process product and/or finished goods; issues Non-conformance Report when such are found.
Accepts, rejects items or reroutes for rework based on established guidelines and knowledge of production techniques.
Gives final disposition in Inventory Control System to raw material, in process product and/or finished goods inspected.
Follows up on corrective actions being taken.
Participate in the establishment of future inspection procedures.
Identifies and participates in continuous improvement projects and programs to achieve work simplification, eliminate non-value-added activities, and cost reduction.
Performs validation/verification activities as per established and approved protocols and First Article inspection activities per established requirements.
Assists in training new personnel on Inspection procedures by providing On the Job Training (OJT).
Follows indications for handling chemical substances and hazardous waste per established procedures, regarding, but not limited to personal protection equipment, respiratory exposure and chemical waste handling.
Audits all Batch Records to ensure completeness and correctness including: a) Reviews for completeness and correctness of Processing, Packaging and Inspections on Batch Records. b) Assures non-conformance closure and that releases are authorized. c) Ensures any required corrective actions in the batch record are completed and in accordance with pre-established procedures and QSR requirements.
Uses computer systems for Inventory Transactions.
Makes recommendations for the redesign or design of batch records for ease of use.