Quality Control Specialist

3 days ago


Fremont, California, United States Fladger Assoc. Inc. Full time
Job Title: QC Associate III

Fladger Assoc. Inc. is seeking a highly skilled QC Associate III to join our team in Fremont, CA.

Job Summary:

We are looking for a detail-oriented and organized individual to perform sampling, testing, and inspection of raw materials, conduct lab investigations, and report aberrant results to management.

Responsibilities:
  • Conduct sampling and testing of raw materials to ensure quality and compliance with regulatory requirements.
  • Perform laboratory investigations and report findings to management.
  • Prepare and distribute samples to testing laboratories, and follow up on test results.
  • Conduct AQL inspections and maintain accurate records.
  • Provide on-call/weekend/swing shift coverage for urgent samples.
  • Enter and review data, and maintain accurate records of QC documentation.
  • Generate and review reports, and maintain records of sample summaries, test records, and other relevant documents.
  • Reconcile samples and perform required reviews of forms and logbooks.
  • Perform an Owner role for Change Controls and Deviations.
  • Prepare and review trend reports, generate metrics, and other reports as needed.
  • Maintain raw material data and revise SOPs, training documents, and other relevant materials.
  • Ensure equipment calibration and preventive maintenance are up to date.
Requirements:
  • Bachelor's Degree in a Scientific Discipline.
  • Five (5) years of cGMP or appropriate experience required.
  • Knowledge of ANSI/ASQ Z1.4, DIN ISO 2859, or other sampling standards desired.
  • Strong technical writing skills required.
  • Knowledge of CFR, USP, and ICH required.
  • Knowledge of SAP Trackwise and LIMS desired.
  • Working knowledge of Microsoft Office systems, LIMS, lab instrumentation, and other relevant systems.
  • Demonstrated problem-detection and problem-resolution skills required.
  • Lifting, carrying, pushing, or pulling up to 50 pounds occasionally.
  • Frequent periods of sitting, walking, and standing.
  • Occasionally must climb stairs or ladders, balance, bend, or stoop, crouch, or squat.
  • Occasional low-level work, fine finger dexterity, including grasping or pinching required.
  • Occasional use of personal protective equipment.
Preferred Skills:
  • GMP, USP, EUROPEAN PHARMACOPIA, MS OFFICE, LIMS.
  • Additional Skills: GMP ISO, ICH.


  • Fremont, California, United States Aerotek Full time

    Job OverviewAs a Quality Control Specialist at Aerotek, you will be responsible for performing complex inspection procedures on CNC machine products and assemblies to ensure quality levels are met. This is a fully on-site position in Fremont, California, working independently with no supervisors present on Sundays.Key ResponsibilitiesVerify CMM program...


  • Fremont, California, United States Hyve Solutions Full time

    Hyve Solutions is seeking a skilled Quality Control Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our products.Key Responsibilities:Conduct thorough inspections of products and processes to identify areas for improvement.Develop and implement quality...


  • Fremont, California, United States Aerotek Full time

    Job Title:Quality Control Inspector (Weekend Shift)Job Description:As a Quality Control Inspector, you will be responsible for performing complex inspection procedures on CNC machine products and assemblies to ensure quality levels are met. This role requires strong analytical and problem-solving skills, as well as the ability to work independently with...


  • Fremont, California, United States Millennium Metalcraft, Inc Full time

    Job Title: Quality Control ManagerWe are seeking a highly skilled Quality Control Manager to join our team at Millennium Metalcraft, Inc. in Fremont, CA.Job Summary:The Quality Control Manager will be responsible for ensuring the quality of our sheet metal and machining products. This includes inspecting parts for dimensional tolerances, craftsmanship, and...


  • Fremont, California, United States Penumbra Full time

    Job Title: Quality Control Training Specialist IIPenumbra is seeking a highly skilled Quality Control Training Specialist II to join our team. This role will be responsible for developing and executing training programs to support the stability and growth of our Quality Inspection environments.Key Responsibilities:Develop and maintain current training...


  • Fremont, California, United States State Water Resources Control Board Full time

    Job Summary:We are seeking a highly skilled Water Resource Management Specialist to join our team at the State Water Resources Control Board. As a key member of our team, you will play a critical role in protecting and restoring environmental water quality in the region.Key Responsibilities:Develop and implement projects to evaluate and resolve cases of...


  • Fremont, California, United States Penumbra Full time

    Job SummaryThe Quality Control Training Specialist II will play a critical role in developing and executing training programs to support the stability and growth of our Quality Inspection environments. This position requires a strong understanding of GMP and Quality processes, as well as excellent project and process management skills.Key...


  • Fremont, California, United States Fladger Assoc. Inc. Full time

    Job Title: QC Associate IIIFladger Assoc. Inc. is seeking a highly skilled QC Associate III to join our team in Fremont, CA. As a key member of our quality control team, you will be responsible for ensuring the highest quality standards in our products.Responsibilities:Perform sampling and testing of raw materials, conduct lab investigations, and report...


  • Fremont, California, United States Pro-Active Pest Control Full time

    Job OverviewPro-Active Pest Control is seeking a highly skilled Pest Control Technician to join our team. As a key member of our team, you will be responsible for providing exceptional customer service and resolving pest problems quickly, safely, and affordably.We pride ourselves on treating our customers like family, and we're looking for someone who shares...


  • Fremont, California, United States Asahi Kasei America Inc Full time

    Job Title: Quality Assurance SpecialistAsahi Kasei America Inc is seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring that products and processes meet established quality standards and regulatory requirements.Job Summary:The Quality Assurance Specialist will be responsible for...


  • Fremont, California, United States QAPEL MEDICAL INC Full time

    Job Title: Quality Systems SpecialistWe are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team at Q'Apel Medical Inc. This role will play a critical part in ensuring the quality and compliance of our medical devices.Key Responsibilities:Process Engineering Change Notices (ECOs) and other Quality Management System...


  • Fremont, California, United States Hyve Solutions Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Hyve Solutions. The ideal candidate will have a strong background in quality control and assurance, with experience in managing production processes and ensuring compliance with ISO standards.The successful candidate will be responsible for reviewing and approving...


  • Fremont, California, United States QAPEL MEDICAL INC Full time

    Job Title: Quality Systems SpecialistAt Q'Apel Medical Inc., we are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team. As a pivotal member of our quality assurance department, you will play a critical role in ensuring the highest level of quality and compliance in our products and processes.Key...


  • Fremont, California, United States Asahi Kasei Full time

    Job Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at Asahi Kasei. The successful candidate will be responsible for ensuring that our products and processes meet established quality standards and regulatory requirements.Key Responsibilities:Conduct audits and implement quality control...


  • Fremont, California, United States Danaher Corporation Full time

    Join Our Team as a Quality Control InspectorWe are seeking a highly skilled Quality Control Inspector to join our team at Danaher Corporation. As a Quality Control Inspector, you will play a critical role in ensuring the quality of our medical devices and equipment.Key Responsibilities:Perform visual and dimensional/mechanical inspection on injection molded...


  • Fremont, California, United States State Water Resources Control Board Full time

    Job Title: Water Resource Control EngineerJoin the State Water Resources Control Board as a Water Resource Control Engineer and contribute to protecting and restoring environmental water quality in the San Francisco Bay Region.Job Summary:We are seeking a highly skilled Water Resource Control Engineer to join our team in the Agricultural Lands Program...


  • Fremont, California, United States Asahi Kasei Full time

    Job DescriptionBionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.Key ResponsibilitiesEnsure products and processes meet established quality...


  • Fremont, California, United States Millennium Metalcraft, Inc Full time

    Job DescriptionMillennium Metalcraft, Inc. is a leading manufacturer of sheet metal and machining products in the Bay Area. We are seeking a skilled Quality Control Inspector to ensure the highest quality standards in our production process.ResponsibilitiesInspect parts for dimensional tolerances, craftsmanship, and cosmetic defectsAnalyze parts against...


  • Fremont, California, United States Asahi Kasei Full time

    Job DescriptionBionova, a subsidiary of Asahi Kasei Medical, is seeking a Quality Assurance Compliance Specialist to join our team. As a rapidly growing biologics CDMO, we are committed to developing and manufacturing recombinant protein products using mammalian cell culture processes.Key ResponsibilitiesEnsure products and processes meet established quality...


  • Fremont, California, United States Tek Support Full time

    Quality Assurance SpecialistWe are seeking an experienced Quality Assurance Specialist to join our team at Tek Support in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.Responsibilities:Regulatory Compliance: Ensure compliance with FDA, ISO 13485,...