Quality Control Technician

Company: TalentBurst, Inc.
Location: Pomona
Posted on: September 18, 2023

Job Description:

Title: Quality Control TechnicianDuration: 6 MonthsLocation: Pomona, CA 91767Shift: 8:30 AM to 5:00 PMSummaryTo support QC functions within our Drugs of Abuse test manufacturing facility.The position will primarily focus on incoming, in-process and final QC testing, labeling, document inspection results and enter raw material inventory data to ensure the quality and functionality of manufactured products.Tasks and responsibilities:Perform and document incoming, in-process, and final QC testing of in-vitro diagnostics devices to meet compliancy requirements including ISO, FDA and international regulations.Document QC test results on QC Testing Form, retain retention samples as needed.Familiarity with all aspects of product and be able to identify defects.Use Agile to issue Quality Incident (QI) reports; perform root cause investigation and write investigation report.Ensure timely release of product.Ensure cleanliness of the QC lab.May be required to work overtime (may include weekends) as defined by the needs of the department.Work effectively and independently. Cooperatively work with others in all matter of the organization.Able to prioritize and handle multiple tasks and responsibilities, attention to detail, Performs well under stress.Good English written and verbal communication skills. Basic computer proficiency.Moderate computer skill and moderate knowledge of MS Excel and MS Word.Assist the head of QC department with any necessary tasks and other duties as assigned.Carries out duties in compliance with established business policies.Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.Perform other duties & projects as assigned.Preferred educational background:BA/BS degree in chemistry or biology or equivalent experience preferred.Preferred experiential background:0-2 years' experience with FDA Class I/II devices or other regulated industry preferred.Proficient in spoken and written English.Excellent interpersonal skills.Excellent computer skills including Microsoft Excel, Word, Agile, and other ERP systems.This is a NonExempt positionSummaryPerform a wide variety of activities to support the Quality Management System.Essential Duties and Responsibilities--- Conduct product testing, including testing to support complaint investigations and stability verification--- Generate product testing results reports--- Review production batch records (DHR's) for accuracy and completeness in order to approve intermediate products for use in production. Review finished goods batch records. Report all deviations in these records and assures these have been addressed and resolved prior to issuing approval.--- Conduct spot-check inspections/audits of production operations--- Participate in the internal audit program--- Write, review and approve Standard Operating Procedures (SOPs) as necessary--- May assist in supporting the Document Control program, record retention areas, and sample retention areas--- May support returned instrument processingo Log returned instruments from the field.o Decontaminate returned instruments in a Biohazard level II environment following standard operating procedure and documenting decontamination as required.o Inspect returned instruments for damage, and performing basic investigation and documenting results prior to second level processing.o As necessary, process instrument documentation for return to repair facility, and pack instruments as required.Other duties as assigned by supervisorSupervisory Responsibilities This job has no supervisory responsibilities.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.Ability to follow Good Manufacturing/Laboratory Practices (GMP and GLP)Education and/or ExperienceBachelor's degree in a scientific or technical area or equivalent combination of experience and education. At least one year in quality assurance role in medical device industry is preferred.Language SkillsAbility to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before small groups of customers or employees of organization.Mathematical SkillsAbility to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.Computer SkillsTo perform this job successfully, an individual should have knowledge of Database software; Internet software; Inventory software; Spreadsheet software and Word Processing software.Certificates, Licenses, Registrations - NoneOther Skills and AbilitiesAbility to follow procedures and accurately document resultsUnderstanding the manufacturing processes of Company products and ability to recognize deviations from approved documented proceduresAttention to detail.Ability to use bleach for cleaning purposes is required.Other Qualifications - NonePhysical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this Job, the employee is regularly required to sit and stand. The employee is occasionally required to walk.Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The noise level in the work environment is usually quiet.TB_HL

Keywords: TalentBurst, Inc., Pomona , Quality Control Technician, Professions , Pomona, California